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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsImmune Responses to Enzyme Replacement Therapies: Role of Immune Tolerance Induction

Meeting Date: 6/9/14-6/9/14

Meeting Details:

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, in cosponsorship with the National Organization for Rare Disorders (NORD), is announcing a 1-day public workshop entitled ‘‘Immune Responses to Enzyme Replacement Therapies: Role of Immune Tolerance Induction.’’ Partners and stakeholders planning the workshop also include representatives from academia, industry, and patients. The purpose of this workshop is to provide a forum to discuss the role of immune tolerance induction in patients receiving replacement biological products.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsRisk Evaluation and Mitigation Strategy Assessments

Meeting Date: 6/7/12-6/7/12

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge.” The purpose of the public workshop is to initiate constructive dialogue and information-sharing among regulators, researchers, the pharmaceutical industry, health care organizations, health care providers, and others from the general public about survey methodologies and instruments that can be used to evaluate patients’ and health care providers’ knowledge about the risks of drugs marketed with an approved REMS. The input from this workshop will be used to develop guidance for industry describing best practices for conducting an assessment of a REMS goal regarding patient and/or health care provider knowledge about a drug’s risk(s). To assist in the workshop discussion and the ultimate development of the guidance, FDA is making available an issue paper that discusses our experience with knowledge assessments for REMS and contains specific questions we hope to receive input on.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsASH/FDA Multiple Myeloma Clinical Endpoints Workshop

Meeting Date: 10/26/06-10/26/06

Meeting Details:

This important workshop on multiple myeloma will explore endpoints that represent clinical benefits other than overall survival in the following areas: Workshop Co-Chairs Kenneth C. Anderson, MD • Dana-Farber Cancer Institute Richard Pazdur, MD • Director, Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration This important workshop on multiple myeloma will explore endpoints that represent clinical benefits other than overall survival in the following areas: Monoclonal Gammopathy of Unclear Significance (MGUS) Subcommittee Chair: Robert A. Kyle, MD • Mayo Clinic, Rochester, MN Newly Diagnosed Subcommittee Chair: S. Vincent Rajkumar, MD • Mayo Clinic, Rochester, MN Relapsed Subcommittee Chair: Donna Weber, MD • M.D. Anderson Cancer Center, Houston, TX Refractory Subcommittee Chair: William S. Dalton, MD, PhD • H. Lee Moffitt Cancer Center, The University of South Florida, Tampa, FL Maintenance Subcommittee Chair: Jean-Luc Harousseau, MD • University Hospital Hôtel-Dieu, Nantes, France

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOverview of the ECG Warehouse and Review Process

Meeting Date: 9/30/05-9/30/05

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop entitled: Overview of the ECG Warehouse and Review Process. The purpose of the workshop is to communicate to industry the logistics of ECG waveform review as a part of the application review process. The ECG Warehouse, an annotated Electrocardiogram waveform data (aECG) storage and review system, is being incorporated into the FDA’s set of tools. This workshop will inform industry how to make aECG source data available to reviewers through the ECG Warehouse. This workshop will also overview the types of information the ECG Warehouse provides reviewers and will give examples of problematic aECGs already found. Traditionally, the Food and Drug Administration (FDA) has received only summary representations of electrocardiogram data for the analysis of safety and efficacy of products. The FDA is interested in improving the evaluation of specific drug-induced cardiac toxicity by evaluating ECG waveform data with detailed, sponsor-generated annotations from the full spectrum of ECG devices including 12-lead standard ECG, Holter monitors, and implanted devices. The FDA entered into a Cooperative Research and Development Agreement with Mortara Instrument, Inc. to develop a data warehouse application and viewing tool for aECG in the format specified in the Health Level Seven standard accredited by the American National Standards Institute. A web-based system supports communication with the sponsor for uploading, receipt, validation, transformation, and warehousing of aECG source data. The warehouse enables the FDA to evaluate aECG source data for evidence of cardiac toxicity and the viewing tool allows reviewers to selectively display waveforms and annotations. FDA is holding a public meeting to communicate the availability of the ECG Warehouse for FDA reviewers and the need for industry to upload aECGs into it. The agenda for this meeting, which will include an overview of the software capabilities and examples of problematic aECGs, will be available on the Internet at http://www.fda.gov/cder/regulatory/ersr/default.htm before the meeting.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:30AM-11:30AM    
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Meeting OptionsMeeting OptionsMeeting OptionsInternational Symposium on Combination Vaccines

Meeting Date: 2/2/00-2/4/00

Meeting Details:

The 3-day International Symposium on Combination Vaccines will explore the laboratory, clinical, and epidemiologic issues that are integral to the development and licensing of new combination vaccines that are both safe and effective. Increased complexity of the recommended childhood immunization schedule has heightened demand for additional combination vaccines that will convey immunity to more than one antigen. Many important benefits can be derived from the use of combination vaccines, including higher rates of immunization—particularly among less accessible populations—and reduced costs. However, a series of scientific and practical challenges will need to be addressed to expedite the widespread development of safe and effective combination vaccines.Among these challenges are (1) the potential for diminished immune response, (2) development, acceptance, and use of correlates of protection, (3) design and analysis of studies to evaluate safety (4) considerations for simultaneous administration, (5) manufacturing, product testing, and preclinical (animal) evaluation, and (6) challenges to use of combination vaccines.

 

       
Location: NIH Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Workshop

Meeting Date: 12/18/96-12/18/96

Meeting Details:

The FDA review clinical safety data.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsGuidance For Industry

Meeting Date: 7/23/96-7/23/96

Meeting Details:

The FDA has outlined a policy for drug development for Juvenile Rheumatoid Arthritis which encourages sponsor licensing products for adult RA to simultaneously obtain dosing and safety data in polyarticular course JRA for inclusion in the dosing and pediatric use sections of the label.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Guidance

Meeting Date: 4/19/96-4/19/96

Meeting Details:

FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products FDA is issuing this guidance document as part of its on-going initiatives to provide manufacturers with increased flexibility to bring important and improved human biological products to market more efficiently and expeditiously. This document addresses the concept of product comparability and describes current FDA practice concerning product comparability of human biological products regulated by the Center for Biologics Evaluation and Research (CBER), including therapeutic biotechnology-derived products, regulated by CBER, and therapeutic biotechnology-derived products regulated by the Center for Drug Evaluation and Research (CDER).

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Public Workshop

Meeting Date: 3/27/96-3/27/96

Meeting Details:

The FDA developed and reviewed the guidelines to assist developers of drugs, biological products, and medical devices intended for the treatment of rheumatoid arthritis (RA). The FDA also discussed the types of label claims that can be considered for such products and provides guidance on the clinical development programs to support those claims.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Workshop

Meeting Date: 2/14/96-2/15/96

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting to pass Public Law 104-180 mandating that the private sector be given the opportunity to meet distribution and quality goals for written patient prescription medicine information.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Workshop

Meeting Date: 12/11/95-12/13/95

Meeting Details:

FDA regulates "Well-characterized" biologicals.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Workshop

Meeting Date: 11/6/95-11/7/95

Meeting Details:

The committee will review the 1993 Gender Studies in Product Development Guideline and to consider the need to provide further clarification.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Workshop

Meeting Date: 9/6/95-9/7/95

Meeting Details:

The subcommittee will hear summary presentations from discussions held during the public workshop on current issues in AIDS clinical trials to be held on September 6 and 7, 1995, (announced elsewhere in this issue of the Federal Register) and discuss recommendations on the scientific design of AIDS clinical trials.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Workshop

Meeting Date: 3/23/95-3/23/95

Meeting Details:

The FDA discussed to improve cost-effectiveness of healthcare.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Workshop

Meeting Date: 3/21/95-3/21/95

Meeting Details:

FDA has taken into consideration relevant issues, concerns, and questions raised at the public meetings held with professional associations, producers of PET drug products, and other interested parties.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic with DSRM

Meeting Date: 9/10/15-9/10/15

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Meeting Details:

The committees will be asked to discuss new drug application (NDA) 206830, oxycodone immediate-release tablets, submitted by Purdue Pharma, with the proposed indication of the management of moderate to severe pain where the use of an opioid analgesic is appropriate. It has been formulated with the intent to provide abuse-deterrent properties. The pharmacokinetic data demonstrate that there is a significant food effect resulting in a significant delay in absorption and peak plasma concentration of oxycodone when taken with food. The applicant proposes to address this finding by labeling the product to be taken on an empty stomach, but patients may have difficulty complying with these instructions as the product is dosed every 4 to 6 hours as needed. The committees will be asked to discuss the potential safety risks and the potential effects on efficacy associated with the delayed peak concentration when taken with food, and the feasibility of labeling to be taken an empty stomach as a means to mitigate the potential risks. The committees will also be asked to consider whether the potential public health benefit of the product’s abuse-deterrent properties are sufficient to outweigh the risk to patients who are prescribed the product for the management of pain.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic with DSRM

Meeting Date: 9/11/15-9/11/15

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Meeting Details:

The committees will discuss new drug application (NDA) 208090, oxycodone extended-release capsules for oral use, submitted by Collegium Pharmaceuticals, proposed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate. This product has been formulated with the intent to provide abuse-deterrent properties. Pharmacokinetic data demonstrate that, in order to deliver the intended amount of oxycodone, the drug product must be taken with food. The committees will be asked to discuss the potential safety risks and the potential effects on efficacy associated with the extent of the food effect, and potential fluctuations in oxycodone levels that may occur if the product is not taken consistently with the same amount of food. In addition, the committees will be asked to review and discuss whether the data characterizing the abuse-deterrent properties support the likelihood that this drug product will have a meaningful effect on abuse and whether potential benefits to the public from abuse-deterrent properties outweigh potential risks to patients from the effect of food. The committees will be asked to vote on whether this product should be approved for marketing in the United States.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory

Meeting Date: 9/15/15-9/15/15

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Meeting Details:

The committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of Seasonal Trivalent Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD) manufactured by Novartis.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-3:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 9/16/15-9/16/15

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Meeting Details:

On Wednesday, September 16, 2015, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA), for DUREZOL (difluprednate ophthalmic emulsion) 0.05%, Phenylephrine Hydrochloride Ophthalmic Solution, ZYLET (loteprednol etabonate and tobramycin ophthalmic suspension), BETHKIS (tobramycin Inhalation Solution), INTELENCE (etravirine), PREZISTA (darunavir), VIRAMUNE XR (nevirapine), EPIDUO (adapalene and benzoyl peroxide), EXJADE (deferasirox), DOTAREM (gadoterate meglumine), FYCOMPA (perampanel), RECOTHROM (thrombin, topical [recombinant]), PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). As mandated by the Food and Drug Administration Amendments Act, Title III, Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110– 85), the committee will discuss the safety of and the ongoing propriety of the humanitarian device exemption for the PLEXIMMUNE, ELANA SURGICAL KIT (HUD), Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD), ENTERRA™ Therapy System, and CONTEGRA Pulmonary Valved Conduit.

 

       
Location: Double Tree by Hilton 8727 Colesville Road Silver Spring, MD 20910 Related News Links: Not Available
Time: 8:00AM-6:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 9/24/15-9/24/15

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Meeting Details:

On September 24, 2015, the committee will discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization. The system, originally approved in November 2002, under P020014, consists of a delivery system and nickel-containing permanent implants. The implants are placed without a skin incision, through the vagina, within each fallopian tube; they elicit tissue ingrowth, which over time results in tubal occlusion.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 10/23/15-10/23/15

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Meeting Details:

The committee will discuss new drug application (NDA) 207988, lesinurad oral tablets, submitted by Ardea Biosciences, Inc., for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm

Meeting Date: 11/3/15-11/3/15

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Meeting Details:

The committee will discuss new drug application (NDA) 207959, enclomiphene citrate 12.5 milligram (mg) and 25 mg capsules, submitted by Repros Therapeutics, Inc., for the proposed treatment of secondary hypogonadism in fertile men (men with more than 15 million sperm/milliliter (ml)), younger than 60 years of age with a Body Mass Index (BMI) over 25 kilograms (kg)/meters squared (m2).

 

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

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