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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 2/12/19-2/12/19

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Meeting Details:

On February 12, 2019, the Committee will discuss and make recommendations regarding the safety and effectiveness of surgical mesh placed transvaginally in the anterior vaginal compartment to treat pelvic organ prolapse. FDA is convening this meeting to seek expert opinion on the evaluation of the risks and benefits of these devices. The Committee will be asked to provide scientific and clinical input on assessing the effectiveness, safety, and benefit/risk of mesh placed transvaginally in the anterior vaginal compartment, as well as identifying the appropriate patient population and physician training needed for these devices.

 

       
Location: Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:30PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm - Sponsor: Sanofi-Aventis US,LLC

Meeting Date: 1/17/19-1/17/19

Meeting Details:

The Committee will discuss new drug application 210934 for sotagliflozin oral tablet, sponsored by Sanofi-Aventis U.S., LLC, for the proposed indication: Adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm - Sponsor: Amgen

Meeting Date: 1/16/19-1/16/19

Meeting Details:

The committee will discuss biologics license application 761062, romosozumab injection, submitted by Amgen, for the proposed indication of treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant of other available osteoporosis therapy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Arthritis & DSRM AdComm - Sponsor: Takeda Pharmaceuticals

Meeting Date: 1/11/19-1/11/19

Meeting Details:

The committees will discuss supplemental new drug application (sNDA) 021-856, ULORIC (febuxostat) tablets, sponsored by Takeda Pharmaceuticals, which includes the results from the postmarketing safety trial required by FDA to evaluate the cardiovascular safety of febuxostat, entitled “Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES).” Febuxostat is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout. The committees' discussion will include the results from the CARES trial, the benefit risk assessment of febuxostat, and potential regulatory actions.

 

       
Location: College Park Marriott Hotel Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Past Meetings

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