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Past Meetings

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    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral Hospital and Personal Use Devices Panel

Meeting Date: 3/5/10-3/5/10

Meeting Details:

On March 5, 2010, the committee will discuss and make recommendations regarding clinical risks and benefits of post-market actions in response to insulin pump failures. Insulin pumps are intended for continuous delivery of insulin at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin.

 

       
Location: Hilton Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral Hospital and Personal Use Devices Panel

Meeting Date: 5/4/07-5/4/07

Meeting Details:

The committee will discuss and make recommendations on the scientific and clinical issues raised by the addition of antimicrobial agents to personal protective equipment (PPE). The PPE to be discussed are surgical masks/respirators, medical gloves, and surgical/isolation gowns.

 

       
Location: T B A Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral Hospital and Personal Use Devices Panel

Meeting Date: 9/27/05-9/27/05

Meeting Details:

The committee will hear a presentation on FDA's Critical Path Initiative. Subsequently, the committee will discuss and make recommendations regarding general issues related to the model used for validation testing to support a claim of decontamination of potentially transmissible spongiform encephalopathy (TSE) contaminated surgical instruments.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral Hospital and Personal Use Devices Panel

Meeting Date: 8/9/05-8/9/05

Meeting Details:

The committee will hear a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of post market study design. The committee will discuss and make recommendations on methods to assess the potential of disease transmission by multiple-use nozzle jet injectors (i.e., jet injectors for which the fluid path for the injection is used more than once). The discussion will include premarket testing recommendations to address this issue

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneric Drugs

Meeting Date: 8/6/95-9/7/95

Meeting Details:

The FDA reviewed performance standards.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 7/14/20-7/14/20

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Meeting Details:

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On July 14, 2020, the committee will discuss biologic license application (BLA) 761158, for belantamab mafodotin, submitted by GlaxoSmithKline Intellectual Property Development Ltd. England. The proposed indication (use) for this product is for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

 

       
Location: TelCon | Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 9:00AM-1:30PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of the ODAC (pedsODAC)

Meeting Date: 6/17/20-6/18/20

Meeting Details:

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On June 17, 2020, information will be presented regarding pediatric development plans for two products that are in development for an adult oncology indication. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate. The two products under consideration are: (1) SP 2577 presentation by Salarius Pharmaceuticals, Inc. and (2) Marizomib, presentation by Celgene International II Sàrl, a wholly owned subsidiary of Bristol-Myers Squibb. On June 18, 2020, information will be presented regarding pediatric development plans for two products that are in development for an adult oncology indication. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate. The two products under consideration are: (1) CD30.CAR-T, presentation by Tessa Therapeutics and (2) SNDX-5613, presentation by Syndax Pharmaceuticals, Inc.

 

       
Location: FDA White Oaak Related News Links: Not Available
Time: 10:00AM-3:30AM    
Materials:
   
       

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Past Meetings

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