FDALiveFDALive.com

The World's Leading Source for FDA Broadcasting

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic with DSRM AdComm

Meeting Date: 7/26/17-7/26/17

.

Meeting Details:

The committees will discuss new drug application (NDA) 209653, for oxycodone hydrochloride extended-release oral tablets, submitted by Intellipharmaceutics Corp., with the proposed indication of management of moderate-to-severe pain when a continuous around the clock analgesic is needed for an extended period of time. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss the overall risk-benefit profile of the product, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 7/28/17-7/28/17

.

Meeting Details:

On July 28, 2017, the Vaccines and Related Biological Products Committee (VRBPAC) will meet in an open session to discuss and make recommendations on the safety and efficacy of a Hepatitis B Vaccine manufactured by Dynavax.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 8/2/17-8/2/17

.

Meeting Details:

The committee will discuss biologics license application (BLA) 761057, for sirukumab injection (proposed trade name PLIVENSIA), submitted by Janssen Biotech, Inc., for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs. The discussion will include dose selection, efficacy, radiographic progression study, and safety.

 

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

View Meeting Details / News

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 7/11/17-7/13/17

Meeting Details:

- DAY 1: - The committee will discuss biologics license application (BLA) 761060, MYLOTARG (gemtuzumab ozogamicin) for intravenous use, submitted by Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. The proposed indication (use) for this product is in combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of adult patients with previously untreated, de novo acute myeloid leukemia (AML). - DAY 2: - The committee will discuss biologics license application (BLA) 125646 for tisagenlecleucel-T suspension for intravenous use. The application was submitted by Novartis Pharmaceuticals Corp. The proposed indication (use) for this product is for the treatment of pediatric and young adult patients 3 to 25 years of age with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). - DAY 3: - During the morning session, the committee will discuss biologics license application (BLA) 761028 for ABP 215, a proposed biosimilar to Genentech/Roche’s AVASTIN (bevacizumab), submitted by Amgen Inc. The proposed indications/uses for this product are: (1) For the first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil-based chemotherapy; (2) in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line ABP 215-containing regimen; (3) for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel; (4) for the treatment of glioblastoma with progressive disease in adult patients following prior therapy as a single agent; (5) for the treatment of metastatic renal cell carcinoma in combination with interferon alfa; and (6) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix. During the afternoon session, the committee will discuss biologics license application (BLA) 761074 for MYL-1401O, a proposed biosimilar to Genentech Inc.’s HERCEPTIN (trastuzumab), submitted by Mylan GmbH. The proposed indications/uses for this product are: (1) For adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer; (a) as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; (b) with docetaxel and carboplatin; or (c) as a single agent following multi-modality anthracycline based therapy; (2) in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer; (3) as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease; and (4) in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

 

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

View Meeting Details / News

Past Meetings

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

Live Meetings

There are no Live Broadcasts available at this time.