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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 5/7/19-5/7/19

Meeting Details:

The committee will discuss the following topics: (1) Approaches to evaluate the effect of renal impairment on drug exposure, and (2) best practice considerations for translating pharmacokinetic (PK) information into dose individualization instructions. Regarding topic 1, many registration trials exclude patients with advanced kidney disease, and product labeling dosing instructions for these patients are commonly derived from our understanding of the change in the PK in individuals with varying degrees of renal function. The most common current approach to determine dosing instructions for patients with varying degrees of renal function begins with a stand-alone renal impairment study, either full design or reduced design. In addition to stand-alone renal impairment studies, drug development programs often use the findings from population PK (POPPK) analyses, which leverage the PK information across all the studies available in a drug development program. An alternative approach to consider is for drug development programs to predict the impact of renal impairment on the PK of the drug, either based on the understanding of the PK of a new molecular entity or using physiologic based PK (PBPK) models, without a stand-alone renal impairment study. Patients with impaired renal function can then be included in later stage clinical trials, with prospective dose adjustment incorporated if deemed necessary based the predictions. The dosing should be confirmed based on analysis of PK samples from the late stage trials (sparse PK, POPPK analysis). Regarding topic 2, dose individualization is typically achieved by applying the concept of `exposure-matching' under the assumption that such a maneuver will result in a benefit-risk similar to that observed in the registration trials. The committee will discuss the application of `exposure matching,' including the necessary assumptions and any limitations.

 

       
Location: TBA Related News Links: Not Available
Time: 9:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 3/15/17-3/15/17

Meeting Details:

The use of model-informed drug development (MIDD) for new and generic drugs has significantly increased over the past several years. The committee will discuss strategies, approaches, and challenges in MIDD with specific focus on two areas. During the morning session, the committee will discuss approaches and evidentiary information needed for applying physiologically-based pharmacokinetic modeling and simulation throughout a drug’s lifecycle. During the afternoon session, the committee will discuss mechanistic model-informed safety evaluation with a focus on drug potential for causing arrhythmias. The Comprehensive in Vitro Proarrhythmia Assay will be discussed as an exemplar.

 

       
Location: Omni Shoreham Hotel The Ballroom 2500 Calvert Street, NW Washington, DC 20008 Related News Links: Not Available
Time: 7:00AM-4:00PM    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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 OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 12/10/19-12/10/19

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Meeting Details:

The committee will be asked to discuss new drug application (NDA) 022034, for vernakalant HCl solution, for intravenous injection, submitted by Correvio International Sàrl, for the proposed indication of rapid conversion of recent onset atrial fibrillation to sinus rhythm for non-surgery patients: Atrial fibrillation = 7 days duration, and for post-cardiac surgery patients: Atrial fibrillation = 3 days duration.

 

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

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm - Sponsor: Amarin Pharma Inc.

Meeting Date: 11/14/19-11/14/19

Meeting Details:

The committee will discuss supplemental new drug application 202057/S-035, for VASCEPA (icosapent ethyl) capsules for oral administration, sponsored by Amarin Pharma Inc., for the following proposed indication: To reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels (135 mg/dL or greater) and other risk factors for cardiovascular disease, based on the results of a clinical study entitled “A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)”

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsImmunology Devices Panel

Meeting Date: 11/13/19-11/14/19

Meeting Details:

On November 13 and 14, 2019, the committee will discuss the topic of immunological responses to metal-containing products regulated as medical devices. The discussion will focus on metal-containing implants as well as dental amalgam. Implants are medical devices that are placed into a surgically or naturally formed opening of the human body and are intended to remain there after the procedure for an extended period of time (typically, greater than 30 days). For decades, metal-containing implants have been used in a large number of medical specialties including cardiology, orthopedics, dentistry, gastroenterology, and neurology or neurosurgery. Recent postmarket issues with some metal-on-metal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological responses to the implant. These may include local (peri-implant) adverse events and potentially systemic manifestations, which may impact a patient's quality of life and necessitate medical or surgical intervention. While not considered an implant, dental amalgam is included in this discussion because of its potential for patient and user exposure to mercury compounds and some purported similarities in the adverse biological responses and clinical manifestations elicited by some dental amalgams to that of traditional metal implants.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm - Sponsor: Boehringer Ingelheim

Meeting Date: 11/13/19-11/13/19

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 204629/S-020 for empagliflozin oral tablet, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the following proposed indication: As an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 11/8/19-11/8/19

Meeting Details:

On November 8, 2019, the Center for Biologics Evaluation and Research's (CBER) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss and make recommendations on the development of chikungunya vaccines.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral Hospital and Personal Use Devices Panel

Meeting Date: 11/6/19-11/7/19

Meeting Details:

On November 6 and 7, 2019, the committee will discuss the topic of industrial ethylene oxide (EtO) sterilization of medical devices and its role in maintaining public health as well as the risks of infection with reprocessed duodenoscopes. Subject matter of the panel meeting will include potential methods and expert assessment of how to reduce EtO emissions to the environment from medical device sterilization processes without compromising assurance of sterility or effective processing of medical devices. The panel will also discuss recommendations to reduce the risk of infection from reprocessed duodenoscopes.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic AdComm
Sponsor: Agile Therapeutics, Inc.

Meeting Date: 10/30/19-10/30/19

Meeting Details:

The committee will discuss new drug application (NDA) 204017 (levonorgestrel and ethinyl estradiol) transdermal system, submitted by Agile Therapeutics, Inc., for the prevention of pregnancy in women of reproductive potential.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm
Sponsor: AMAG Pharmaceuticals

Meeting Date: 10/29/19-10/29/19

Meeting Details:

The committee will discuss supplemental new drug application (sNDA 021945/S-023#) for MAKENA (hydroxyprogesterone caproate injection, 250 milligrams per milliliter) manufactured by AMAG Pharmaceuticals. In 2011, MAKENA received approval under the accelerated approval pathway (21 CFR part 314, subpart H, and section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) for reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. MAKENA was shown in the preapproval clinical trial to reduce the proportion of women who delivered at less than 37 weeks gestation, a surrogate endpoint that FDA determined was reasonably likely to predict a clinical benefit of preterm birth prevention, such as improved neonatal mortality and morbidity. As required under 21 CFR 314.510, the Applicant conducted a postapproval confirmatory clinical trial to verify and describe clinical benefit. AMAG Pharmaceuticals has disclosed that this completed confirmatory trial did not demonstrate a statistically significant difference between the treatment and placebo arms for the co-primary endpoints of reducing the risk of recurrent preterm birth or improving neonatal mortality and morbidity. The committee will consider the trial's findings and the sNDA in the context of AMAG Pharmaceuticals' confirmatory study obligation.

 

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

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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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