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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 OptionsFDA Rare Disease Day 2020:
Supporting the Future of Rare Disease Product Development

Meeting Date: 2/24/20-2/24/20

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Meeting Details:

The Food and Drug Administration (FDA or the Agency) is announcing a public meeting and an opportunity for public comment on “FDA Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development.” Developing a treatment for a rare disease can present unique challenges. The goal of this meeting is to obtain stakeholder’s perspectives on challenges and solutions in rare disease product development and identify commonalities that can support product development across a variety of rare diseases.

 

       
Location: FDA White Oak | Great Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 2/26/20-2/26/20

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Meeting Details:

During the morning session, the committee will discuss new drug application 212578 for padeliporfin di-potassium powder for solution for injection, submitted by STEBA Biotech, S.A. The proposed indication (use) for this product is for the treatment of patients with localized prostate cancer, meeting the following criteria: Stage T1-T2a and prostate specific antigen less than or equal to 10 ng/mL and Gleason Grade Group 1 based on transrectal ultrasound guided biopsy or unilateral Gleason Grade Group 2 based on multiparametric magnetic resonance imaging-targeted biopsy with less than 50 percent of cores positive. During the afternoon session, the committee will discuss supplemental biologics license application 125477/S-034, for CYRAMZA (ramucirumab) injection for intravenous use, submitted by Eli Lilly and Company. The proposed indication (use) for this product is in combination with erlotinib, for first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 3/4/20-3/4/20

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Meeting Details:

On March 4, 2020, under Topic I, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2020 to 2021 influenza season. Also, on March 4, 2020, under Topic II, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Respiratory and Special Pathogens (LRSP), Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, CBER.

 

       
Location: White Oak Related News Links: Not Available
Time: 8:30AM-5:10PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs Advisory Committee

Meeting Date: 3/11/20-3/11/20

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Meeting Details:

In the Agency's document entitled “Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information” (December 7, 2018, 83 FR 63168) (Docket No. FDA-2018-N-3458), FDA sought input on the current use of over-the-counter antiseptics in the food handler setting and the recommended testing criteria to establish the safety and effectiveness of these products. Now that the comment period has closed, FDA plans to hold an advisory committee meeting to review the information submitted and discuss its key points.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsTobacco Products Scientific Advisory Committee Meeting

Meeting Date: 2/14/20-2/14/20

Meeting Details:

On February 14, 2020, the Center for Tobacco Products (CTP) Tobacco Products Scientific Advisory Committee (TPSAC) will meet in open session to discuss discuss the modified risk tobacco product applications, submitted by 22nd Century Group Inc. for the following combusted filtered cigarette tobacco products: MR0000159: VLNTM King MR0000160: VLNTM Menthol King

 

       
Location: The Great Room FDA White Oak Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsThe Oncology Center of Excellence (OCE)
Envisioning Oncology Product Development for 2025

Meeting Date: 2/5/20-2/5/20

Meeting Details:

The Oncology Center of Excellence (OCE), Envisioning Oncology Product Development for 2025

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-1:00PM    
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Past Meetings

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

Live Meetings

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