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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    
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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 OptionsPediatric Advisory Committee

Meeting Date: 4/21/14-4/21/14

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Meeting Details:

On April 21, 2014, the Pediatric Advisory Committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107–109) and the Pediatric Research Equity Act (Pub. L. 108–155). The PAC will meet to discuss Activa Dystonia Therapy, ADVATE (antihemophilic factor (recombinant)), FAMVIR (famciclovir), INTELENCE (etravirine), KEPPRA (levetiracetam), MAXALT and MAXALT MLT (rizatriptan), NATAZIA (estradiol valerate and estradiol valerate/dienogest), PERTZYE (pancrelipase), PERZISTA (darunavir), REYATAZ (atazanavir), SKLICE (ivermectin), TISSEEL (fibrin sealant), TORISEL (temsirolimus), ULTRESA (pancrelipase), Vertical Expandable Prosthetic Titanium Rib (VEPTR), and VIREAD (tenofovir disoproxil fumarate).

 

       
Location: Bethesda Marriott 5151 Pooks Hill Road Bethesda, MD 20814 Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drugs AdComm

Meeting Date: 4/22/14-4/22/14

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Meeting Details:

The committee will discuss the safety and efficacy for new drug application 203077, MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, QRxPharma Inc., for the proposed indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. This product represents the first drug combination consisting of two immediate-release opioids.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 4/24/14-4/24/14

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Meeting Details:

On April 24, 2014, the committee will discuss the current knowledge about the safety and effectiveness of aversive conditioning devices that are intended to deliver a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. FDA is convening this committee to seek clinical and scientific expert opinion on the risks and benefits of certain aversive conditioning devices based on available scientific data and information. The Agency is considering whether to ban aversive conditioning devices that are intended to administer a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. The meeting will concern only devices classified under 21 CFR 882.5235 (aversive conditioning device, class II) that are not self-administered. Devices which deliver a noxious electrical stimulus automatically are not considered to be self-administered devices. Section 516 of the FD&C Act (21 U.S.C. 360f) sets forth the standard for banning devices. Under that provision, in order to ban a device, FDA must make a finding that a device "presents substantial deception or an unreasonable and substantial risk of illness or injury" based on all available data and information. FDA regulations provide additional details about the procedures and standards for banning a device (21 CFR part 895).

 

       
Location: Holiday Inn - Main Ballroom 2 Montgomery Village Ave. Gaithersburg, MD 20879 Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 5/2/14-5/2/14

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Meeting Details:

The committee will discuss data submitted by MSD Consumer Care, Inc., to support a new drug application (NDA) 204804 for over-the-counter (OTC) marketing of montelukast 10 milligram (mg) tablets (proposed trade name SINGULAIR Allergy). The proposed OTC use is "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose.” The applicant proposes to label the product for OTC use in adults 18 years and older. Efficacy and safety data, as well as results of consumer studies, will be discussed. The committee will be asked to consider whether the data support an acceptable risk/benefit profile for the nonprescription use of montelukast tablets by OTC consumers.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsRisk Communication AdComm

Meeting Date: 5/5/14-5/6/14

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Meeting Details:

On May 5-6, 2014, the Committee will meet to discuss methods for identifying the impact and increasing the reach of communications on topics of interest to consumers. The discussion will also address how FDA can evaluate whether its Consumer Updates (http://www.fda.gov/ForConsumers/ConsumerUpdates/default.htm disclaimer icon ) are reaching the targeted population, and whether they are increasing awareness and understanding of the key risk messages. The discussion will also assess whether the communications are having the intended impact on knowledge, behaviors and/or outcomes.

 

       
Location: The Great Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 5/6/14-5/7/14

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Meeting Details:

On May 6, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the RESQCPR System sponsored by Advanced Circulatory Systems, Inc. The RESQCPR System is comprised of two devices: the RESQPOD 16.0 Impedance Threshold Device, and the RESQPUMP Active Compression Decompression CPR Device. These devices are used together during manual cardiopulmonary resuscitation (CPR) in an attempt to enhance venous return to the heart and blood flow to vital organs during CPR to ultimately increase survival and neurologic outcome in patients suffering from out of hospital cardiac arrest. Advanced Circulatory Systems, Inc. has proposed the following indications for use: the RESQCPR System is intended for use in the performance of CPR to increase survival with favorable neurologic function in adult patients with non-traumatic cardiac arrest. On May 7, 2014, during session I, the committee will discuss and make recommendations regarding the classification of membrane lung for long-term pulmonary support systems, one of the remaining preamendment Class III devices regulated under the 510(k) pathway. A membrane lung for long-term pulmonary support refers to the oxygenator component of an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). An ECMO procedure provides assisted extracorporeal circulation and physiologic gas exchange of a patient's blood when an acute (reversible) condition prevents the patient's own body from providing the physiologic gas exchange needed to sustain life. The circuit is comprised of multiple device types, including, but not limited to, an oxygenator, blood pump, cannulae, heat exchanger, tubing, filters, monitors/detectors, and other accessories; the circuit components and configuration (e.g., arteriovenous, veno-venous) may differ based on the needs of the individual patient or the condition being treated. ECMO is currently used for patients with acute reversible respiratory or cardiac failure, unresponsive to optimal ventilation and/or pharmacologic management.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 5/13/14-5/13/14

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Meeting Details:

On May 13, 2014, the committee will discuss and make recommendations regarding the guidance documents for contact lenses and contact lens accessories.

 

       
Location: Holiday Inn Germantown, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 4/1/14-4/1/14

Meeting Details:

The committee will discuss new drug application (NDA) 22-472, proposed trade name AFREZZA (TECHNOSPHERE Insulin Inhalation System), 3 unit and 6 unit cartridges for oral inhalation, manufactured by MannKind Corporation. The proposed indication (use) for this application is to improve glycemic control in adult patients with type 1 or type 2 diabetes mellitus.

 

       
Location: College Park Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 3/31/14-3/31/14

Meeting Details:

During the morning session, the committee will discuss new drug applications (NDAs) 205-435 and 205-436, tedizolid phosphate tablets and tedizolid phosphate injection, submitted by Trius Therapeutics, respectively, for the proposed indication of treatment of acute bacterial skin and skin structure infections. During the afternoon session, the committee will discuss NDA 021-883, dalbavancin hydrochloride for intravenous injection, submitted by Durata Therapeutics International B.V., for the proposed indication of treatment of acute bacterial skin and skin structure infections.

 

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

Meeting Date: 3/27/14-3/27/14

Meeting Details:

The committee will discuss biologics license application 125468, serelaxin injection, submitted by Novartis, as a treatment to improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMolecular and Clinical Genetics Panel

Meeting Date: 3/26/14-3/27/14

Meeting Details:

On March 26, 2014, the committee will discuss, make recommendations and vote on information related to the premarket approval application sponsored by Epigenomics, Inc. for the Epi proColon. The Epi proColon test is a qualitative in vitro diagnostic method for the detection of methylated Septin 9 DNA in plasma derived from patient whole blood specimens. Methylation of the target Septin 9 DNA sequence has been associated with the occurrence of colorectal cancer (CRC). The test is indicated to screen patients for CRC who are defined as average risk for CRC by current screening guidelines. The Epi proColon test is not intended to replace colorectal screening by colonoscopy. Patients with a positive Epi proColon test result should be referred for diagnostic colonoscopy. The Epi proColon test results are intended to be used in conjunction with the physician's assessment of history, other risk factors, and professional guidelines. On March 27, 2014, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Cologuard device, sponsored by Exact Sciences. Cologuard is an in vitro diagnostic device designed to analyze patients' stool for detection of hemoglobin, multiple DNA methylation and mutational markers, and the total amount of human DNA. Cologuard is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer or premalignant colorectal neoplasia. Cologuard is not intended as a replacement for colonoscopy. Cologuard is intended to be used in conjunction with colonoscopy and other test methods in accordance with recognized screening guidelines.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 3/20/14-3/20/14

Meeting Details:

On March 20, 2014, the committee will discuss, make recommendations, and vote on information regarding the humanitarian device exemption (HDE) application for the XVIVO Perfusion System (XPSTM) sponsored by XVIVO Perfusion, Inc. The proposed Indication for Use for the XVIVO Perfusion System, as stated in the HDE, is as follows: The XPSTM is intended to be used with STEEN Solution for flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the function of the lungs can be reassessed for transplantation.

 

       
Location: Holiday Inn, GBurg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

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