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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsNational Mammography Quality Assurance Advisory Committee

Meeting Date: 4/19/04-4/19/04

Meeting Details:

The committee will discuss the following issues: (1) mechanisms to reduce the regulatory and inspection burden on facilities; (2) whether mammographic images obtained from reconstructed compressed digital data (lossless or lossy data compression) can be used for primary interpretation or storage; (3) whether images obtained from digitized film-screen mammograms can be used for primary interpretation or storage; and (4) revisions to MQSA compliance guidance. The committee will also receive updates on recently approved alternative standards, full field digital mammography accreditation and certification, the inspection demonstration program, the status of MQSA reauthorization, and the new post inspection enforcement strategy.

 

       
Location: Holiday Inn Related News Links: Not Available
Time: 9:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNational Mammography Quality Assurance Advisory Committee

Meeting Date: 11/2/98-11/3/98

Meeting Details:

On November 2, 1998, the committee will discuss the proposed Mammography Quality Standards Act (MQSA) compliance guidance under the final regulations. On November 3, 1998, the committee will receive updates on the issues of States as Certifying Bodies under MQSA, Congressional Reauthorization of MQSA, and Voluntary Stereotactic Accreditation Programs.

 

       
Location: Gaithersburg Hilton Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNational Mammography Quality Assurance

Meeting Date: 5/4/98-5/5/98

Meeting Details:

On May 4, the committee will discuss the proposed Mammography Quality Standards Act (MQSA) inspection procedures under the final regulations. On May 5, the committee will discuss the issue of collimation of the x-ray field as it relates to mammography and receive updates on the issues of States as certifying bodies under MQSA, Interventional Mammography, and Voluntary Stereotactic Accreditation Programs.

 

       
Location: Gaithersburg Hilton, Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 7/25/19-7/25/19

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Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 205832 for nintedanib capsules (drug name OFEV), sponsored by Boehringer Ingelheim, for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). The focus of the discussion will be whether the application provides substantial evidence of efficacy for the proposed indication.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm

Meeting Date: 7/31/19-7/31/19

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Meeting Details:

The committee will discuss new drug application (NDA) 209500, lumateperone tosylate capsules for oral administration, submitted by Intra-Cellular Therapies, Inc., for the treatment of schizophrenia.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs Advisory Committee

Meeting Date: 8/7/19-8/7/19

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Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 208215, supplement 12, DESCOVY (emtricitabine 200 milligrams (mg) and tenofovir alafenamide 25 mg tablets), submitted by Gilead Sciences, Inc., proposed for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-2:30PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of ODAC

Meeting Date: 6/20/19-6/20/19

Meeting Details:

During the morning session, the particular matter for this meeting will be review and discussion of the FDA Reauthorization Act of 2017 (FDARA) mandated Relevant Pediatric Molecular Target List now posted on the FDA website: https://www.fda.gov/?AboutFDA/?CentersOffices/?OfficeofMedicalProductsandTobacco/?OCE/?ucm544641.htm. FDA is required by statute to review and update the previously approved and published lists. The focus of the discussion will be limited to two target “classes” included in the Relevant Pediatric Molecular Target List: (1) Targets linked to cell lineage and (2) targets on normal immune cells and cells in the tumor microenvironment. Planned introductory presentations will be on: (1) Cell-based therapy approaches to childhood cancer and (2) novel membrane antigen determinants in pediatric tumors. During the afternoon session, information will be presented to gauge investigator interest in exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) ONC201, presentation by Oncoceutics Inc., and (2) CD24Fc, presentation by OncoImmune, Inc.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 6/19/19-6/20/19

Meeting Details:

On June 19 and 20, 2019, the committee will discuss and make recommendations on information related to recent observations of increased long-term mortality in peripheral arterial disease patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared to patients treated with uncoated comparator devices. FDA requests panel input regarding the presence and magnitude of the signal and potential causes. FDA also seeks input regarding appropriate regulatory actions associated with the findings.

 

       
Location: Gaithersburg Holiday Inn Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Past Meetings

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