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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsTechnical Electronic Product Radiation Safety Standards Committee

Meeting Date: 5/22/02-5/22/02

Meeting Details:

The committee will hear an informal review of ongoing activities associated with electronic products. Following the overview, FDA will discuss its concern about radiation doses associated with x-ray computed tomography (CT), and its current thinking about amending the U.S. performance standard for x-ray CT imaging procedures. Specifically FDA will address possible requirements for: (1) definition and standardization of CT terminology; (2) display of an index of patient radiation dose that could be automatically recorded within a facility quality assurance program; (3) automatic exposure control through modulation of x-ray tube output according to patient dimensions; and (4) limitation of the x-ray field size to that needed for image formation. In the afternoon, FDA will discuss proposed amendments to the U.S. performance standard for sunlamp products and certain initiatives of international standards organizations concerning sunlamp products. In the final session, FDA will be considering mandatory standards for x-ray security screening systems; FDA will discuss public health considerations regarding these systems that use ionizing radiation.

 

       
Location: Hilton Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 8/13/20-8/13/20

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Meeting Details:

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On August 13, 2020, the committee will discuss biologics license application (BLA) 125706, for remestemcel-L (ex-vivo culture-expanded adult human mesenchymal stromal cells suspension for intravenous infusion), submitted by Mesoblast, Inc. The proposed indication (use) for this product is for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients. The morning session will discuss issues related to the characterization and critical quality attributes of remestemcel-L as they relate to clinical effectiveness. The afternoon session will discuss results from clinical trials included in BLA 125706.

 

       
Location: 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: 8:00AM-5:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee Meeting

Meeting Date: 7/15/20-1/15/20

Meeting Details:

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On July 15, 2020, the committee will be asked to discuss new drug application (NDA) 22231, terlipressin, lyophilized powder for solution for injection,submitted by Mallinckrodt Pharmaceuticals, for the proposed indication of treatment of hepatorenal syndrome Type 1.

 

       
Location: 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-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

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

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    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

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

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-1:30AM    
Materials:
   
       

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Past Meetings

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