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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 OptionsVaccines and Related Biological Products Advisory

Meeting Date: 9/15/15-9/15/15

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Meeting Details:

The committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of Seasonal Trivalent Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD) manufactured by Novartis.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 9/24/15-9/24/15

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Meeting Details:

On September 24, 2015, the committee will discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization. The system, originally approved in November 2002, under P020014, consists of a delivery system and nickel-containing permanent implants. The implants are placed without a skin incision, through the vagina, within each fallopian tube; they elicit tissue ingrowth, which over time results in tubal occlusion.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 7/9/15-7/9/15

Meeting Details:

The committee will discuss biologics license application 125547, necitumumab injection, application submitted by Eli Lilly and Company. The proposed indication (use) for this product is in combination with gemcitabine and cisplatin for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer.

 

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

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Past Meetings

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