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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsCancelled - Pharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 10/30/13-10/31/13

Meeting Details:

There will be two topics presented to the committee for their discussion and consideration. During the first session, the Office of Pharmaceutical Science and the Office of Compliance will discuss with the committee the use of statistical methods for the evaluation of pharmaceutical product quality. The committee will receive presentations from the Agency on the need for objective metrics of product quality and some of the available statistical methods used by other industries in their quality assurance programs. Representatives from the pharmaceutical industry will provide the manufacturers' perspective. During the second session, the committee will receive an update and status on research activities within the Office of Pharmaceutical Science supporting regulatory decision making. There will be presentations from the Office of Generic Drugs, the Office of Testing and Research, and the Office of Biotechnology Products. This will be an awareness topic and there will not be formal committee discussion or recommendation.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 9/25/13-9/25/13

Meeting Details:

The committee will discuss optimal strategies for the evaluation, interpretation, and communication of drug-drug interaction (DDI) information. FDA will seek input on: (1) best practices in DDI communication through prescription drug product labels (i.e., “package inserts”), namely: a) appropriate format for presentation (e.g. tables, graphs, text) of DDI information; b) level of detail of DDI study results; and c) appropriate wording for clinical recommendations based on empirical data vs. anticipated interactions; (2) appropriate criteria for determining whether or not to describe DDI information derived from the literature in product labels; and (3) how package insert information on DDIs is used by various end-users (e.g., prescribers, dispensers, DDI database curators) in decision making and/or communication.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology

Meeting Date: 8/9/12-8/9/12

Meeting Details:

During the morning session, the committee will discuss FDA’s draft guidance on tablet scoring. This topic will include an overview of FDA’s proposed plan to move forward and the United States Pharmacopoeia’s perspective on the topic. During the afternoon session, the committee will discuss: (1) The Center for Drug Evaluation and Research (CDER) Nanotechnology Risk Management Working Group activities; (2) nanotechnology-related research conducted and published by CDER, to include examples related to sunscreens; and (3) the overview and preliminary analysis of nanotechnology-related information collected from drug application submissions.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology

Meeting Date: 8/8/12-8/8/12

Meeting Details:

During the first session, the committee will discuss the uses and limitations of in vitro dissolution testing and propose future direction for evaluation including possible research. During the second session, the committee will receive an update on the FDA’s recently posted draft guidances for industry on biosimilar products. This will be an awareness topic and there will not be formal Committee discussion or recommendation.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology

Meeting Date: 3/14/12-3/14/12

Meeting Details:

The committee will discuss the clinical pharmacology aspects of pediatric clinical trial design and dosing to optimize pediatric drug development. FDA will seek input on how to strategically inform pediatric clinical trial design and dosing by utilizing existing knowledge, including available adult and nonclinical data. The discussion will include the role of modeling and simulation including physiologically-based pharmacokinetic modeling in pediatric drug development. Modeling and simulation is the application of mathematical approaches to predicting what will happen in a clinical trial with pediatric patients when a particular dose of a drug is used.

 

       
Location: Gaylord National Hotel and Convention Center Related News Links: Not Available
Time: 7:30AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement

Meeting Date: 7/26/11-7/26/11

Meeting Details:

The committee will discuss presentations by the Office of Generic Drugs (OGD) on bioequivalence issues and quality standards relative to narrow therapeutic index (NTI) drug products as a class. In response to feedback during the April 13, 2010, Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (ACPS-CP) meeting, the committee will further discuss the definition and list of NTI drugs, as well as proposed bioequivalence standards for these products. The committee will also receive awareness presentations relevant to OGD’s ongoing focus on quality and safety of generic drug products. Presentations will outline current activities seeking to better understand the impact of formulation and quality on the performance of generic drug products and current thinking related to potential regulatory pathways for these issues.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:30AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology

Meeting Date: 3/2/11-3/2/11

Meeting Details:

The committee will discuss innovative approaches to the development of drugs for orphan and rare diseases to support decisions such as dose and trial design selection. FDA will seek input and comment on how to optimally utilize mechanistic biomarkers and apply clinical pharmacology tools, such as pharmacogenetics and modeling and simulation, to facilitate efficient and informative drug development and regulatory review. FDA will present and seek input from the committee on how lessons learned from other applications of clinical pharmacology tools in pediatrics and oncology can be applied to orphan and rare disease drugs. The committee will be asked to comment on the current status and future direction for clinical pharmacology studies (e.g., dose-response, drug-drug interactions, pharmacokinetics in patients with renal or hepatic impairment) as they pertain to drug development for orphan and rare diseases

 

       
Location: Dallas Texas Related News Links: Not Available
Time: 7:00AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology

Meeting Date: 4/14/10-4/14/10

Meeting Details:

On April 14, 2010, the committee will: (1) Receive presentations from the Office of Generic Drugs (OGD) on a proposal for revision of the bioequivalence (BE) approaches, specifically to discuss the addition of a limitation on point estimates; (2) receive presentations on an awareness topic to highlight some issues associated with product instability (failure of a marketed product to meet stability specifications through the expiration date), and the potential research needs to address those issues; and (3) receive and discuss presentations from Office of Pharmaceutical Science (OPS) on the regulatory challenges of drug-induced phospholipidosis (excessive intracellular accumulation of phospholipids, a kind of fatty molecule, due to the use of certain drugs).

 

       
Location: Hilton Washington DC/Silver Spring Silver Spring, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science

Meeting Date: 4/13/10-4/13/10

Meeting Details:

On April 13, 2010, the committee will receive presentations from the Office of Generic Drugs and discuss two bioequivalence topics relevant to generic drug approval: (1) Revising the BE approaches for critical dose drugs and (2) the use of partial area under the curve (AUC) for the evaluation of abbreviated new drug applications for products with complex pharmacokinetic profiles. Bioequivalence refers to the evaluation of equivalence in the rate and extent of drug absorption between two preparations of the same drug. Critical dose drugs are medicines that require a narrow (or ``critical'') dose range to achieve and maintain their intended effects and to reduce serious adverse drug reactions. The ``area under the curve'' is the area under a plot of drug concentration in the bloodstream versus time; it is a measure of the extent of exposure to a drug after a dose is administered.

 

       
Location: Hilton Silver Spring MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 8/5/09-8/5/09

Meeting Details:

The committee will: (1) Receive a status update from the Office of Generic Drugs (OGD) on bioequivalence for highly variable drugs (highly variable means that the rate and amount of the drug entering blood varies significantly from one administration to another); (2) receive presentations from the Office of Pharmaceutical Science (OPS) on the scientific and regulatory challenges of Transdermal Drug Delivery Systems (TDDS); (3) receive presentations from OPS and discuss current thinking on ‘‘Classifying Pre-Surgical Preparations as Sterile Products’’ in consideration of how these products are used; and (4) be updated by OPS on the current status of the International Conference on Harmonization (ICH) Quality Topics [i.e., those relating to chemical and pharmaceutical quality assurance (stability testing, impurity testing, etc.)], and outline the role of the ICH Implementation Work Group (Q IWG), its future activities, and any remaining gaps and challenges.

 

       
Location: Hilton Silver Spring MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology Adcom

Meeting Date: 8/4/09-8/4/09

Meeting Details:

The committee will discuss bioequivalence recommendations for oral vancomycin hydrochloride capsule drug products.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAdvisory Committee for Pharmaceutical Science and Clinical Pharmacology

Meeting Date: 7/22/08-7/23/08

Meeting Details:

On July 22, 2008, the committee will do the following: (1)Receive presentations from the Office of Pharmaceutical Science (OPS) and discuss current thinking on issues pertaining to the use of nanotechnology in drug manufacturing, drug delivery, or drug products, and (2) receive an update from OPS, discuss, and make comments on current strategies and directions for the testing of lead in pharmaceutical products. On July 23,2008, the committee will do the following: (1)Receive and discuss presentations from the Office of Generic Drugs (OGD) on the bioequivalence methods for locally acting drugs that treat gastrointestinal (GI) conditions, (2) receive and discuss presentations from OGD on the use of inhaled corticosteroid dose-response as a means to establish bioequivalence of inhalation drug products, and (3) receive and discuss presentations from OPS on the drug classification of orally disintegrating tablets (ODT) as a separate dosage form, and the need for subsequent guidance on expectations and recommendations that would be required for applications proposing the dosage form.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology

Meeting Date: 3/18/08-3/19/08

Meeting Details:

On March 18, 2008, the committee will: (1) Discuss and provide comments on three new topics of this meeting; first new topic: The new clinical pharmacogenomics (PGx) concept paper. Key issues in the concept paper include an industry survey on the collection of PGx samples, and the applications of PGx in clinical development will be presented and (2) discuss and provide comments on the second new topic: Quantitative clinical pharmacology: Critical path opportunities. An example of a disease model and its applications will be presented. The regulatory experience, designs, and implications of pediatric studies will be discussed. On March 19, 2008, the committee will consider the third new topic: Renal impairment concept paper. The effects of renal impairment on Cytochrom P (CYP)/transporter, methods of evaluation of renal function, and the effects of hemodialysis on drug clearance will be discussed.

 

       
Location: TBA Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCancelled: Pharmaceutical Science and Clinical Pharmacology

Meeting Date: 5/1/07-5/2/07

Meeting Details:

On May 1, 2007, the committee will do the following: (1) Receive and discuss updates from the October 18 and 19, 2006, Clinical Pharmacology Subcommittee Meeting and the April 30, 2007, Manufacturing Subcommittee Meeting; (2) receive an update, discuss and make comments on current strategies and directions for the Critical Path Initiative; (3) receive an update and discuss revisions to the FDA draft guidance for industry entitled ``Comparability Protocols -- Chemistry, Manufacturing, and Controls Information;'' (4) discuss current thinking on risk-based approaches to managing post-approval activity. On May 2, 2007, the committee will do the following: (1) Receive an update from the Office of Generic Drugs (OGD) on the bioequivalence of highly variable drugs, (2) receive an update on and discuss general strategies within the OGD pertaining to the bioequivalence of narrow therapeutic index drug products, and (3) discuss and provide comments on the topic of alcohol-induced dose dumping.

 

       
Location: TBA Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCancelled: Manufacturing Subcommittee

Meeting Date: 4/30/07-4/30/07

Meeting Details:

The subcommittee will do the following: (1) As an awareness topic, discuss issues pertaining to the stability of tablets split for patient use; (2) receive a general update and discuss current strategies on quality by design and the Office of Generic Drugs' question-based review; and (3) receive an update on and discuss the status of the Office of New Drug Quality Assessment Chemistry, Manufacturing, and Controls Pilot Program.

 

       
Location: TBA Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsClinical Pharmacology Subcommittee

Meeting Date: 10/18/06-10/19/06

Meeting Details:

On October 18, 2006, the subcommittee will: (1) Receive an update on previous Clinical Pharmacology Subcommittee meeting recommendations and an introduction to three new topics of this meeting; (2) discuss and provide comments on the first new topic: The scope and strength of evidence to support the inclusion of pharmacogenetic information on Cytochrome P2D6 polymorphisms in a revision of the label for tamoxifen to improve the benefit/risk of the drug; and (3) discuss and provide comments on the second new topic: evaluation of transporter-based drug interactions. On October 19, 2006, the subcommittee will consider the third new topic: The impact of using prior knowledge on drug development and regulatory decisions. Prior knowledge of disease change over time and covariates, placebo variation and drug effects can be used to make better decisions and design more informative clinical trials. Examples will be used to demonstrate these principles.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science AdComm

Meeting Date: 10/5/06-10/6/06

Meeting Details:

On October 5, 2006, the committee will: (1) Receive an update on the International Conference on Harmonization Quality Topics (Q8, Q9, Q10, Q4B, QOS) and discuss the impact on current regulatory direction, and (2) receive and discuss a series of presentations from the different offices within the Office of Pharmaceutical Science on progress being made on quality-by-design (QBD) initiatives, followed by presentations from the pharmaceutical industry trade associations (The Generic Pharmaceutical Association [GPhA] and The Pharmaceutical Research and Manufacturers of America [PhRMA]) on their QBD perspectives and issues. On October 6, 2006, the committee will: (1) Receive an awareness presentation on risk management for complex pharmaceuticals, (2) receive presentations and discuss bioequivalence issues pertaining to highly variable drugs, (3) discuss current thinking on issues and definitions pertaining to nanotechnology, (4) discuss implementation of definitions for topical dosage forms, and (5) receive an update and discuss current strategies and direction for the Critical Path Initiative.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsManufacturing Subcommittee of the Pharmaceutical Science AdComm

Meeting Date: 4/18/06-4/19/06

Meeting Details:

Meeting Cancelled !!! - On April 18, 2006, the subcommittee will: (1) Receive topic updates for ongoing activities pertaining to the International Conference on Harmonisation (ICH) Q8, Q9, Q10, and future ICH quality topics; and (2) discuss and provide comments on modernized Current Good Manufacturing Practice (CGMP) approaches to process validation that encourage continuous improvement over the product life-cycle. On April 19, 2006, the subcommittee will: (1) Discuss and provide comments on the agency’s new approaches to Chemistry, Manufacturing, and Control (CMC) guidance development, as illustrated by the comparability protocol guidance; (2) discuss and provide comments on the CMC Pilot Program; and (3) receive an update on the Cooperative Research and Development Agreement (CRADA) with Conformia Software, Inc., to obtain information on factors influencing pharmaceutical development.

 

       
Location: TBA Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsClinical Pharmacology Subcommittee

Meeting Date: 11/14/05-11/15/05

Meeting Details:

On November 14, 2005, the subcommittee will: (1) Receive an update on previous Clinical Pharmacology Subcommittee meeting recommendations and an introduction to the topics of this meeting, (2) discuss and provide comments on the evidence and process for translation of pharmacogenetic information (e.g., Cytochrome P 2C9 polymorphisms) into label updates for approved products, (3) discuss current evidence related to the pharmacogenetics of warfarin as a potential basis for label updates, and (4) discuss and provide comments on the critical path pilot project, the End-of-Phase 2A meetings which will include a case study. On November 15, 2005, the subcommittee will discuss and and provide comments on: (1) An update on the critical path biomarker-surrogate endpoint project, (2) the use of biomarker information in labels to facilitate individualizing pharmacotherapy, and (3) the analytical and clinical validation criteria for approving a clinical assay ("diagnostic test").

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science AdComm

Meeting Date: 10/25/05-10/26/05

Meeting Details:

On October 25, 2005, the committee will do the following: (1) receive an update on current activities of the Parametric Tolerance Interval Test Workgroup; (2) receive and discuss presentations from the Pharmaceutical Research and Manufacturing Association, the Generic Pharmaceutical Association, and the United States Pharmacopeia pertaining to their perspectives on the general topic of Quality-by-Design (QBD) and drug release or dissolution specification setting; and (3) discuss and provide comments on the updated tactical plan under development for the establishment of drug release or dissolution specifications. On October 26, 2005, the committee will do the following: (1) discuss and provide comments on the general QBD topics of question-based review and alcohol-induced dose dumping; and (2) receive and discuss an update on the establishment of a workgroup for the review and assessment of Office of Pharmaceutical Science research programs. Following those items, an awareness topic will be introduced concerning the need to enhance the pharmaceutical education system in the United States.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science

Meeting Date: 5/3/05-5/4/05

Meeting Details:

On May 3, 2005, the committee will: (1) Receive an update from the Clinical Pharmacology Subcommittee and (2) discuss and provide comments on the general topic of establishing drug release or dissolution specifications. On May 4, 2005, the committee will: (1) Receive an update on current activities of the Parametric Tolerance Interval Test Workgroup, (2) discuss and provide comments on the general topic of considerations for assessment of pharmaceutical equivalence and product design, and (3) discuss criteria for establishing a working group for review and assessment of Office of Pharmaceutical Science research programs.

 

       
Location: FDA - Rockville Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsClinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science

Meeting Date: 11/3/04-11/4/04

Meeting Details:

On November 3, 2004, the subcommittee will: (1) Receive topic updates for ongoing FDA activities previously presented to the subcommittee; (2) discuss and provide comments on the evidence for updating labels of approved drugs to include integrating pharmacogenetic, pharmacokinetic, and prognostic biomarkers for the purpose of optimizing therapeutic response and reducing risks of toxicity; and (3) discuss and provide comments on metabolism- and transporter-based drug-drug interactions included as recommendations in a draft guidance for industry being prepared by FDA. On November 4, 2004, the subcommittee will discuss and provide comments on a new critical path project related to general aspects of the transition of biomarkers to surrogate endpoints, with a focus on planning and process, rather than on specific biomarkers or surrogate endpoints.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science Advisory Committee

Meeting Date: 10/19/04-10/20/04

Meeting Details:

On October 19, 2004, the committee will do the following: (1) receive updates pertaining to the Manufacturing Subcommittee, the Parametric Tolerance Interval Test (PTIT) Workgroup, and the Good Manufacturing Practices (GMPs) for the 21st Century Initiative, and (2) review and discuss research opportunities under the Critical Path Initiative. On October 20, 2004, the committee will do the following: (1) review and discuss the Office of Pharmaceutical Science (OPS) plans and activities designed to take the organization towards the ‘‘desired state’’ of science and risk-based regulatory policies and practices as articulated under the GMPs for the 21st Century Initiative, and (2) review and discuss specific topics related to pharmaceutical equivalence and bioequivalence of generic drugs.

 

       
Location: FDA Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsManufacturing Subcommittee of the Pharm Science AdComm

Meeting Date: 7/20/04-7/21/04

Meeting Details:

On July 20, 2004, the subcommittee will address the following issues: (1) Receive topic updates for ongoing activities pertaining to manufacturing science and quality by design; and (2) discuss and provide comment on a Current Good Manufacturing Practice (cGMP) risk model being developed at FDA. On July 21, 2004, the subcommittee will address the following issues: (1) Discuss and provide comments on a cGMP and quality system approach for the production of investigational new drugs (INDs) and (2) discuss and provide comments on manufacturing science and risk-based questions for new drug application chemistry, manufacturing and controls (NDA CMC) review process.

 

       
Location: Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science Advisory Committee

Meeting Date: 4/13/04-4/14/04

Meeting Details:

On April 13, 2004, the committee will receive an update from the Clinical Pharmacology Subcommittee. The committee will also discuss and provide comments on the following topics: (1) a proposal for resolving the issues related to the parametric tolerance interval test for dose content uniformity for inhalation products, (2) the Process Analytical Technologies progress and next steps, and (3) process analytical technology for products in the Office of Biotechnology Products, Center for Drug Evaluation and Research and in the Center for Biologics Evaluation and Research. On April 14, 2004 the committee will discuss and provide comments on the following topics: (1) Bioequivalence testing/methods strategy for products exhibiting high variability and (2) bioinequivalence concepts and definition

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsClinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science

Meeting Date: 11/17/03-11/18/03

Meeting Details:

On November 17, 2003, the subcommittee will discuss: (1) Quantitative analysis using exposure-response: Proposal for End-of-Phase2A (EOP2A) meeting and use of clinical trial simulation for PK-QT study design; and (2) pediatric decision tree: Examples for applying the pediatric decision tree. On November 18, 2003, the subcommittee will discuss the pediatric decision tree: (1) Use of clinical trial simulation in pediatric population pharmacokinetics study design; (2) drug interactions; and (3) pharmacogenetics: Integration into new drug development.

 

       
Location: FDA Rockville, MD Related News Links: Not Available
Time: 8:30AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAdvisory Committee for Pharmaceutical Science

Meeting Date: 10/21/03-10/22/03

Meeting Details:

On October 21, 2003, the committee will: (1) receive updates from the Manufacturing, Clinical Pharmacology, and Pharmacology/Toxicology Subcommittees; (2) discuss and provide comments on draft FDA Guidance for Industry entitled, "Process Analytical Technologies (PAT) - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance," see the FDA internet web address www.fda.gov/cder/guidance/5815dft.htm; and (3) discuss and provide comments on parametric tolerance interval test for dose content uniformity. On October 22, 2003, the committee will: (1) discuss and provide comments on risk based Chemistry Manufacturing and Control review proposals; (2) discuss and provide comments on nomenclature; and (3) discuss and provide direction to the research plan for generics.

 

       
Location: Best Western Rockville, MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsManufacturing SubCommittee of the Pharm Science AdComm

Meeting Date: 9/17/03-9/18/03

Meeting Details:

On September 17, 2003, the subcommittee will discuss quality by design and how it is distinct from the approaches that attempt to test in qualities. On September 18, 2003, the subcommittee will discuss and define principles by which risk management is integrated into decision making.

 

       
Location: FDA Rockville, MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science Advisory Committee - Pharmacology & Toxicology

Meeting Date: 6/10/03-6/10/03

Meeting Details:

The committee will review and discuss issues relating to the format and content of genome scale gene expression data generated during nonclinical pharmacology and toxicology investigations and the submission of this data to the agency.

 

       
Location: FDA Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAdvisory Committee for Pharmaceutical Science - Manufacturing Subcommittee

Meeting Date: 5/21/03-5/22/03

Meeting Details:

On May 21, 2003, the subcommittee will discuss: (1) The mission of the subcommittee; and (2) direction of the Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century: A Risk-Based Approach. On May 22, 2003, the subcommittee will discuss: (1) The regulatory approaches regarding aseptic manufacturing; and (2) process analytical technologies and transition from the Advisory Committee for Pharmaceutical Science-Process Analytical Technologies Subcommittee to Manufacturing Subcommittee.

 

       
Location: Marriott - Rio Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsClinical Pharmacology Subcommittee of the Pharmaceutical Science Advisory Committee

Meeting Date: 4/22/03-4/23/03

Meeting Details:

On April 22, 2003 the subcommittee will dicuss (1) quanitative risk benefit analysis using exposure response for determining dose adjustment for special populations and (2) pediatric population pharmacokinetic study design template and analysis of the FDA pediatric database. On April 23, the subcommittee will discuss pharmacogenetics improvement of drug treatments 2 drug interactions metabolism and transport based.

 

       
Location: CDER Conference Room Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsManufacturing Subcommittee - Meeting Postponed

Meeting Date: 3/21/03-3/21/03

Meeting Details:

On March 12, 2003, the committee will: 1) receive a final report from the Process Analytical Technology Subcommittee and provide direction to the Manufacturing Subcommittee; 2) receive an update on sterile products produced by aseptic processing; 3) discuss and provide direction for future subcommittees - Biopharmaceutics Subcommittee and Microbiology Subcommittee; 4) discuss and provide comments on topical dermatological drug product nomenclature; and 5) discuss and provide comments on topical dermatological bioequivalence - methods development. On March 13, 2003, the committee will: 1) discuss and provide direction for future subcommittee - Pharmacology/Toxicology Subcommittee; 2) receive an update on OPS research projects; 3) discuss and provide comments on dose content uniformity - parametric interval test for aerosol products; 4) discuss and provide comments on levothyroxine bioequivalence; and 5) discuss and provide comments on comparability protocols.

 

       
Location: FDA - Fishers Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science Advisory Committee

Meeting Date: 3/12/03-3/13/03

Meeting Details:

On March 12, 2003, the committee will: (1) Receive a final report from the Process Analytical Technology Subcommittee and provide direction to the Manufacturing Subcommittee; (2) receive an update on sterile products produced by aseptic processing; (3) discuss and provide direction for future subcommittees: Biopharmaceutics Subcommittee and Microbiology Subcommittee; (4) discuss and provide comments on topical dermatological drug product nomenclature; and (5) discuss and provide comments on topical dermatological bioequivalence, methods development. On March 13, 2003, the committee will: (1) Discuss and provide direction for future subcommittee: Pharmacology/Toxicology Subcommittee; (2) receive an update on the Office of Pharmaceutical Science research projects; (3) discuss and provide comments on dose content uniformity, parametric interval test for aerosol products; (4) discuss and provide comments on levothyroxine bioequivalence; and (5) discuss and provide comments on comparability protocols.

 

       
Location: FDA - Fishers Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsClinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science

Meeting Date: 10/23/02-10/23/02

Meeting Details:

The subcommittee will discuss: (1) Consideration of investigational pharmacokinetic studies to identify patient populations at risk, (2) methods used to adjust dosing given the availability of exposure-response information, (3) use of exposure-response relationships in the Pediatric Study Decision Tree, (4) questions to be asked of the pediatric database, and (5) scientific and practical considerations in the use of pharmacogenetic tests to determine drug dosage and administration.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsProcess Analytical Technologies Subcommittee of the Advisory Committee for Pharmaceutical Science

Meeting Date: 10/23/02-10/23/02

Meeting Details:

The subcommittee will discuss: 1) computer systems validation - Part 11 issues pertinent to Process Analytical Technologies (PAT); 2) a PAT case study; and 3) rapid microbiology testing.

 

       
Location: TBA Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAdvisory Committee for Pharmaceutical Science

Meeting Date: 10/21/02-10/22/02

Meeting Details:

On October 21, 2002, the committee will: 1) receive summary reports and provide direction for the Nonclinical Studies Subcommittee and the Process Analytical Technologies Subcommittee; 2) receive updates on risk-based CMC review and blend uniformity; and 3) discuss and provide comments on regulatory issues related to crystal habits -polymorphism. On October 22, 2002, the committee will: 1) discuss and provide direction for future subcommittee - GMP/Manufacturing Subcommittee; and 2) manufacturing issues; sterile drug products produced by aseptic processing.

 

       
Location: TBA Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNonclinical Studies Subcommittee of the Pharmaceutical Science AdComm

Meeting Date: 9/9/02-9/10/02

Meeting Details:

On September 9, 2002, the Chair of the expert working group on cardiotoxicity will report on the progress and activities of the group and the subcommittee will be allotted time to discuss the report. The subcommittee will then discuss a plan to transfer oversight of the subcommittee from the Advisory Committee for Pharmaceutical Science to the Science Advisory Board of the National Center for Toxicological Research. On September 10, 2002, the Chair of the expert working group on vascular damage will report on the progress and activities of the group and the subcommittee members will be allotted time to discuss the report.

 

       
Location: CDER Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science Advisory Committee

Meeting Date: 6/12/02-6/13/02

Meeting Details:

On June 12 2002, the subcommittee will: (1) Identify and define technology and regulatory uncertainties/hurdles, possible solutions, and strategies for the successful implementation of process analytical technologies (PATs) in pharmaceutical development and manufacturing; (2) discuss general principles for regulatory application of PATs including principles of method validation, specifications, use and validation of chemometric tools, and feasibility of parametric release concept; and (3) discuss the need for a general FDA guidance to facilitate the implementation of PATs. On June 13, 2002, the subcommittee will discuss strategies to explore issues in the following four focus areas: (1) Product and process development, (2) process and analytical validation, (3) chemometrics, and (4) process analytical technologies, applications and benefits.

 

       
Location: Hilton Gaithersburg, Md. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science Advisory Committee

Meeting Date: 5/7/02-5/8/02

Meeting Details:

On May 7, 2002, the committee will: (1) Discuss the current status of, and future plans for, the draft FDA guidance entitled ``Guidance for Industry, Food-Effect Bioavailability and Fed Bioequivalence Studies: Study Design, Data Analysis, and Labeling'' (see the FDA Internet address www.fda.gov/cder/guidance/4613dft.PDF under ``Biopharmaceutics (Draft) Guidances''); (2) discuss and provide comments on the biopharmaceutic classification system; and (3) discuss and provide direction for future subcommittees. On May 8, 2002, the committee will: (1) Receive summary reports and provide direction for the Process Analytical Technology Subcommittee; (2) discuss and provide comments on regulatory issues related to crystal habits-polymorphism; (3) discuss problems and provide comments to form a scientific basis for establishment of acceptance limits for microbiological tests that use newly developed technologies that do not rely on colony counts and their application as process controls and product release criteria; and (4) discuss the current status of, and future plans for, the draft FDA guidance entitled ``Guidance for Industry, ANDAs: Blend Uniformity Analysis'' (see FDA Internet address www.fda.gov/cder/guidance/ 2882dft.PDF under ``Generics (Draft) Guidances'').

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsSubcommittee for Pharmaceutical Science

Meeting Date: 2/25/02-2/26/02

Meeting Details:

On February 25, 2002, the subcommittee will: (1) Identify and define technology and regulatory uncertainties/hurdles, possible solutions, and strategies for the successful implementation of process analytical technologies (PATs) in pharmaceutical development and manufacturing; (2) discuss general principles for regulatory application of PATs including principles of method validation, specifications, use and validation of chemometric tools, and feasibility of parametric release concept; and (3) discuss the need for a general FDA guidance to facilitate the implementation of PATs. On February 26, 2002, the subcommittee will discuss strategies to explore issues in the following four focus areas: (1) Product and process development, (2) process and analytical validation, (3) chemometrics, and (4) process analytical technologies, applications and benefits.

 

       
Location: Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science Advisory Committee

Meeting Date: 11/28/01-11/29/01

Meeting Details:

On November 28, 2001, the committee will: 1) discuss the current status of, and future plans for, the draft FDA guidance entitled "ANDAs: Blend Uniformity Analysis, 2) discuss and provide direction for the process Analytical technology Subcommittee, 3) discuss and provide comments on stability testing and shelf-life, and 4) receive updates from subcommittees and on other CDER guidance documents. On November 29, 2001, the committee will: 1) receive updates on FDA research in dermatopharmacokinetics and 2) discuss and provide comments on bioequivalence issues.

 

       
Location: Rockville MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Sciences Drugs Advisory Committee

Meeting Date: 11/13/01-11/13/01

Meeting Details:

The subcommittee will discuss the activities of the two expert working groups requested by this subcommittee: The working group on biomarkers of cardiac tissue injury and the working group on biomarkers of vasculitis (vascular damage). Representatives from each working group will report their progress and plans, and the subcommittee will discuss these activities and provide feedback to the working groups. Administrative oversight of the subcommittee will be discussed, including the possibility of integration with the Scientific Advisory Board of the FDA National Center for Toxicological Research.

 

       
Location: Fishers Lane Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science Advisory Committee

Meeting Date: 7/19/01-7/20/01

Meeting Details:

On July 19, the committee will (1) Discuss specific recommendations of the Orally Inhaled and Nasal Drug Products Subcommittee regarding dose response of locally acting nasal sprays and nasal aerosols, with particular application to bioequivalence studies; (2) hear reports and provide direction to the Nonclinical Studies Subcommittee; (3) provide comments and advice to the Risk-Based Chemistry, Manufacturing, and Controls Review Working Group for establishment of a list of low risk drugs; (4) discuss and provide direction on optimal applications of inline process controls in pharmaceutical production; and (5) discuss problems and provide comments to form a scientific basis for establishment of acceptance limits for microbiological tests that use newly developed technologies that do not rely on colony counts, and their application as process controls and product release criteria. On July 20, the committee will (1) Provide comments and advice on methods to determine drug transfer into breast milk and interpretation of data; and (2) discuss and provide comments on the feasibility, scientific challenges, and approaches for establishment of pharmaceutical equivalence, bioavailability, and bioequivalence of liposome drug products.

 

       
Location: Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOrally Inhaled and Nasal Drug Subcommittee

Meeting Date: 7/17/01-7/17/01

Meeting Details:

The subcommittee meeting will discuss the issue of dose-response of locally acting nasal sprays and nasal aerosols, with particular application to bioequivalence studies.

 

       
Location: Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science Advisory Committee

Meeting Date: 5/3/01-5/3/01

Meeting Details:

The subcommittee meeting will discuss strategies to identify promising areas of nonclinical scientific research to develop biomarkers and/or other evolving molecular technologies to identify or predict: (1) Drug-induced cardiac tissue injury, and (2) drug-induced vasculitis.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAdvisory Committee for Pharmaceutical Science

Meeting Date: 11/17/00-11/17/00

Meeting Details:

On November 17, 2000, the committees will discuss the current status of, and future plans for, the draft FDA guidance entitled ``A Guidance for Industry, Topical Dermatological Drug Product NDA's and ANDA's--In Vivo Bioavailability, Bioequivalence, In Vitro Release, and Associated Studies;'' A proposed research program for addressing scientific issues related to this guidance will also be discussed.

 

       
Location: Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science Advisory Committee

Meeting Date: 11/15/00-11/16/00

Meeting Details:

On November 15, 2000, the committee will: (1) Discuss approaches to reducing the regulatory burden for chemistry, manufacturing, and controls supplements; and (2) hear reports and provide direction to the Advisory Committee for Pharmaceutical Science's Subcommittee on Orally Inhaled and Nasal Drug Products, and to the Subcommittee on Nonclinical Studies. On November 16, 2000, the committee will: (1) Discuss the FDA guidance entitled ``A Guidance for Industry, Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System,''

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmacuetical Science - Orally Inhaled and Nasal Drug Products

Meeting Date: 4/26/00-4/26/00

Meeting Details:

The subcommittee will discuss specific scientific issues where the additional expertise of the subcommittee is needed to aid the agency in refining draft guidances for orally inhaled and nasal drug products in the areas of: (1) Chemistry, manufacturing, and controls; and (2) in vitro and in vivo bioavailability/bioequivalence.

 

       
Location: Rockville, MD. Related News Links: Not Available
Time: 8:30AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science

Meeting Date: 3/9/00-3/9/00

Meeting Details:

The subcommittee meeting will discuss collaborative approaches to scientific research issues of common interest to the pharmaceutical industry, universities, the public, and FDA. Specific areas of focus will be in the nonclinical studies areas of: (1) Interspecies biomarkers of toxicity and (2) noninvasive imaging.

 

       
Location: Rockville, MD. Related News Links: Not Available
Time: 8:30AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science

Meeting Date: 12/14/99-12/14/99

Meeting Details:

The subcommittee will discuss collaborative approaches to scientific research issues of common interest to the pharmaceutical industry, universities, the public, and FDA. Specific areas of focus will be in the nonclinical studies areas of: (1) Interspecies biomarkers of toxicity, (2) high-resolution magnetic imaging, (3) positron emission tomography imaging, and (4) methods to facilitate early human assessments.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmacuetical Science

Meeting Date: 9/23/99-9/24/99

Meeting Details:

On Sept. 23, the committee will discuss individual bioequivalence- criteria for equivalence comparisons. On Sept. 24, the committee will discuss clinical pharmacology- pharmacokinetic/pharmacodynamic issues in drug development and research issues in nonclinical studies.

 

       
Location: Center for Drug Evaluation and Research Advisory Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmacuetical Science Site-Specific Stability Subcommittee

Meeting Date: 9/22/99-9/22/99

Meeting Details:

The subcommittee will discuss the March site-specific stability proposal from the agency and the public comments submitted to Docket No. 98D-0362.

 

       
Location: Center for Drug Evaluation and Research Advisory Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science

Meeting Date: 10/22/98-10/22/98

Meeting Details:

October 22nd will be devoted to discussion on bioavailability/bioequivalence (BA/BE) issues related to solid oral dosage forms. Discussion will also include progress reports on guidances pertaining to the biopharmaceutical classification system, other BA/BE guidances, and criteria (average, population, and individual) to allow comparison of BE measures/parameters.

 

       
Location: CDER Advisory Committee Room Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science

Meeting Date: 6/23/98-6/24/98

Meeting Details:

On June 23 and 24, 1998, the Committee will focus on both safety/efficacy and quality topics with a bridging topic (exposure). Specific topis to be discussed include nonclinical/nonhuman pharmacology/toxicology research programs to support the drug development and registartion process, in vitro drug metabolism to support guidance updating; the revision of the guidance for scale-up and post-approval changes for immediate release drug products; and complex drug substances.

 

       
Location: Holiday Inn, Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Sciences

Meeting Date: 12/11/97-12/12/97

Meeting Details:

On December 11, 1997, the committee will discuss the Biopharmaceutics Classification System, topicals-dermatological drug products, and Narrow Therapeutic Index Drugs and relevance to product quality testing. On December 12, 1997, the committee will discuss the drug-drug interaction studies, and bioequivalence studies that fail to meet established confidence intervals.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science Advisory Committee

Meeting Date: 5/7/97-5/8/97

Meeting Details:

The committee discussed biopharmaceutics and chemistry policy and research issues of pharmacology / toxicology research programs.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Pharmaceutical Science, Pulmonary & Allergy Drugs Advisory Committee

Meeting Date: 8/16/96-8/16/96

Meeting Details:

The committees will discuss Bioequivalence of Albuterol Metered Dose Inhalers (MDI's).

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAdvisory Committee for Pharmaceutical Science

Meeting Date: 8/15/96-8/15/96

Meeting Details:

On August 15, 1996, the committee will discuss the Biopharmaceutics Drug Classification System and Individual Bioequivalence. On August 16, 1996, the committee will discuss Product Quality Research, Laboratory-Based Clinical Pharmacology Research, and Clinic-Based Clinical Pharmacology Research.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 7/30/14-7/31/14

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Meeting Details:

On July 30, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc. The proposed Indication for Use for the Ablatherm Integrated Imaging device, as stated in the PMA, is as follows: The Ablatherm Integrated Imaging device is intended for the primary treatment of prostate cancer in subjects with low risk, localized prostate cancer. On July 31, 2014, the committee will discuss and make recommendations regarding the classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Penile Tumescence Monitors are currently regulated under the heading, ``Monitor, Penile Tumescence,' Product Code LIL, as unclassified under the 510(k) premarket notification authority. Nephrostomy Catheters are currently regulated under the heading, ``Catheter, Nephrostomy,' Product Code LJE, as unclassified under the 510(k) premarket notification authority. Stimulators for Electrical Sperm Collection are currently regulated under the heading, ``Stimulator, Electrical for Sperm Collection,' Product Code LNL, as unclassified under the 510(k) premarket notification authority. Erectile Dysfunction Devices are currently regulated under the heading, ``Device, Erectile Dysfunction,' Product Code LST, as unclassified under the 510(k) premarket notification authority. Alloplastic Spermatoceles are currently regulated under the heading, ``Spermatocele, Alloplastic,' Product Code LQS, as unclassified under the 510(k) premarket notification authority. FDA is seeking committee input on the safety and effectiveness and the regulatory classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/1/14-8/1/14

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Meeting Details:

On August 1, 2014, the committee will discuss, make recommendations and vote on information regarding the premarket application (PMA) for the TissuGlu Surgical Adhesive device sponsored by Cohera Medical, Inc. The proposed indication for use for the TissuGlu Surgical Adhesive device, as stated in the PMA is as follows: TissuGlu Surgical Adhesive is indicated for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsConfidentiality of Interim Results in Cardiovascular Outcome Safety Trials

Meeting Date: 8/11/14-8/11/14

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Meeting Details:

The Food and Drug Administration (FDA) is announcing a public hearing that will provide a forum to discuss confidentiality of interim results for certain cardiovascular outcomes trials (CVOTs) submitted to the Agency while the trials are still ongoing. The purpose of the public hearing is to initiate constructive discussion among regulators, researchers, health care providers, representatives from the pharmaceutical industry and health care organizations, and the general public, about appropriate handling of interim analysis results of these ongoing CVOTs. FDA is also opening a public docket to receive comments on this topic.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 8/14/14-8/14/14

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Meeting Details:

he committee will discuss the new drug application (NDA) 21936, for tiotropium bromide inhalation spray, submitted by Boehringer Ingelheim Pharmaceuticals, Inc. for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and for reducing COPD exacerbations. The discussion will include efficacy data, including the data to support the claim for reduction of COPD exacerbations, but the focus will be on safety findings from the clinical development program and the results of a large safety trial comparing tiotropium bromide inhalation spray and tiotropium bromide inhalation powder.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 9/3/14-9/5/14

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Meeting Details:

The committee will discuss the standards used to demonstrate that over-the-counter (OTC) topical antiseptics used in healthcare settings are generally recognized as safe and effective. The discussion will focus on antiseptic active ingredients marketed under the OTC Drug Review (also known as the OTC Drug Monograph) for the following healthcare antiseptic uses: healthcare personnel hand washes and rubs, surgical hand scrubs and rubs, and patient preoperative and preinjection skin preparations. On September 4-5, 2014, the committee will discuss the scope of safety testing that should be required for sunscreen active ingredients to be marketed in U.S. over-the-counter (OTC) sunscreen products. This discussion will take into consideration that sunscreens are typically used chronically in individuals over the age of 6 months to help prevent skin cancer and skin aging. The need for various types of safety data, including clinical data and nonclinical data, will be discussed.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 9/9/14-9/9/14

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Meeting Details:

The committee will discuss new drug application (NDA) 206302, nebivolol/valsartan fixed-dose combination tablets (5/80 milligrams (mg), 5/160 mg, 10/160 mg, 10/320 mg and 20/320 mg), submitted by Forrest Laboratories, Inc., for the proposed indication of the treatment of hypertension.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 12:00PM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMethodological Considerations in Evaluation of Cancer

Meeting Date: 9/10/14-9/11/14

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Meeting Details:

Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting; Public Meeting; Request for Comments The Food and Drug Administration (FDA), in collaboration with the National Cancer Institute (NCI), is announcing a public meeting entitled ‘‘Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting.’’ The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry, public health agencies, health care providers, and the general public concerning challenges in designing and implementing postapproval studies to evaluate the risk of cancer associated with use of non-oncological drugs and biological products. The input from this meeting and public docket will be used to inform the Agency on best study design and methodological options to consider when evaluating cancer risk in the postapproval setting.

 

       
Location: The DoubleTree by Hilton Hotel Washington DC—Silver Spring The Pinnacle Grand Ballroom 8727 Colesville Road Silver Spring, MD 20910 Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs

Meeting Date: 9/10/14-9/10/14

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Meeting Details:

The committee will be asked to discuss the potential clinical utility of fixed-combination prescription drugs composed of an anti-hypertensive drug, aspirin, and a statin administered to reduce the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke in patients with a history of cardiovascular disease. The committee will be asked to discuss the patient population that could benefit from such a product, whether that population would be likely to take such a drug long term, and how this could be assured. The committee will also be asked to consider the pros and cons of a treatment that would not be titrated and in a setting where monitoring might not be rigorous.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AC

Meeting Date: 9/12/14-9/12/14

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Meeting Details:

The committee will discuss biologics license application (BLA) 125511, proposed trade name NATPARA (established name: Recombinant Human Parathyroid Hormone (rDNA) or (rhPTH[1-84]), submitted by NPS Pharmaceuticals, Inc., for the proposed indication of replacement for endogenous parathyroid hormone (1-84) for the long-term treatment of hypoparathyroidism.

 

       
Location: Marriott Inn and Conference Center Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm

Meeting Date: 9/17/14-9/18/14

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Meeting Details:

The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use.

 

       
Location: College Park Marriott Hotel Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 9/23/14-9/23/14

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Meeting Details:

The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act for: AFINITOR DISPERZ (everolimus); Berlin Heart EXCOR® Pediatric Ventricular Assist Device; CONTEGRA® Pulmonary Valved Conduit; DYMISTA (azelastine hydrochloride; fluticasone propionate); Elana Surgical Kit; ENTERRA Therapy System; LEVAQUIN (levofloxacin); LEXIVA (fosamprenavir calcium); QNASL (beclomethasone diproprionate), Medtronic Melody® Transcatheter Pulmonary Valve; MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine); SINGULAIR (montelukast sodium); TREANDA (bendamustine hydrochloride); VERAMYST (fluticasone furoate); VIREAD (tenofovirdisoproxil fumarate); and VOLUVEN (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection).

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs & DSRM

Meeting Date: 10/16/14-10/16/14

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Meeting Details:

The committees will discuss the risk of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate) tablets, NDA 21928, Pfizer, Inc., and discuss options for addressing this risk.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 10/20/14-10/20/14

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Meeting Details:

The committee will discuss biologics license application (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 7/30/14-7/31/14

Meeting Details:

On July 30, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc. The proposed Indication for Use for the Ablatherm Integrated Imaging device, as stated in the PMA, is as follows: The Ablatherm Integrated Imaging device is intended for the primary treatment of prostate cancer in subjects with low risk, localized prostate cancer. On July 31, 2014, the committee will discuss and make recommendations regarding the classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Penile Tumescence Monitors are currently regulated under the heading, ``Monitor, Penile Tumescence,' Product Code LIL, as unclassified under the 510(k) premarket notification authority. Nephrostomy Catheters are currently regulated under the heading, ``Catheter, Nephrostomy,' Product Code LJE, as unclassified under the 510(k) premarket notification authority. Stimulators for Electrical Sperm Collection are currently regulated under the heading, ``Stimulator, Electrical for Sperm Collection,' Product Code LNL, as unclassified under the 510(k) premarket notification authority. Erectile Dysfunction Devices are currently regulated under the heading, ``Device, Erectile Dysfunction,' Product Code LST, as unclassified under the 510(k) premarket notification authority. Alloplastic Spermatoceles are currently regulated under the heading, ``Spermatocele, Alloplastic,' Product Code LQS, as unclassified under the 510(k) premarket notification authority. FDA is seeking committee input on the safety and effectiveness and the regulatory classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 7/10/14-7/11/14

Meeting Details:

On July 10 and 11, 2014, the committee will discuss the safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures, based on available scientific data. The committee will make recommendations regarding the appropriate use, premarket testing, labeling, and other risk mitigations (including the use of containment bags) for these devices. On July 11, 2014, during the afternoon session, the committee will also be asked to discuss the regulatory classification of laparoscopic power morcellator devices when used to cut and extract tissue during gynecologic laparoscopic procedures and to assist FDA in determining the appropriate level of regulatory control necessary for this device type, including discussion of class II (special controls) or reclassification to class III (subject to premarket approval application (PMA)).

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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