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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices AdComm

Meeting Date: 2/23/17-2/23/17

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Meeting Details:

On February 23, 2017, the committee will discuss and make recommendations on clinical information related to the de novo request for the Sentinel® Cerebral Protection System, a first of a kind embolic protection device to be used with transcatheter aortic valve replacement (TAVR) procedures.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee Meeting

Meeting Date: 3/6/17-3/7/17

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Meeting Details:

On Monday, March 6, 2017, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA), for NITROPRESS (sodium nitroprusside), KUVAN (sapropterin dihydrochloride) and TRUVADA (emtricitabine/tenofovir disoproxil fumarate). On Tuesday, March 7, 2017, as mandated by the Food and Drug Administration Amendments Act, Title III, Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110– 85), the committee will discuss the safety of and the ongoing propriety of the humanitarian device exemption for: EPICEL (cultured epidermal autografts) (HDE), IMPELLA RP SYSTEM (HDE), LIPOSORBER LA-15 SYSTEM (HDE), MEDTRONIC ACTIVA DYSTONIA THERAPY (HDE).

 

       
Location: tbd Related News Links: Not Available
Time: 8:30AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 3/9/17-3/9/17

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Meeting Details:

On March 9, 2017, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2017-2018 influenza season.

 

       
Location: National Institutes of Health (NIH) Fishers Lane Conference Center (T-Terrace Level) 5635 Fishers Lane Rockville, MD 20852-1722 Related News Links: Not Available
Time: 8:30AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the DSRM AdComm and the Anesthetic and Analgesic Drug Products AdComm

Meeting Date: 3/13/17-3/14/17

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Meeting Details:

The committees will be asked to discuss safety issues for new drug application (NDA) 201655, OPANA ER (oxymorphone hydrochloride) Extended-release Tablets, by Endo Pharmaceuticals Inc., with the indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an approved extended-release (ER) formulation intended to have abuse-deterrent properties based on its physicochemical properties, however, this information is not currently reflected in product labeling. The committees will be asked to discuss pre- and post-marketing data about the abuse of OPANA ER, and the overall risk-benefit of this product. The committees will also discuss abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products.

 

       
Location: tbd Related News Links: Not Available
Time: 9:15AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 3/15/17-3/15/17

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Meeting Details:

The use of model-informed drug development (MIDD) for new and generic drugs has significantly increased over the past several years. The committee will discuss strategies, approaches, and challenges in MIDD with specific focus on two areas. During the morning session, the committee will discuss approaches and evidentiary information needed for applying physiologically-based pharmacokinetic modeling and simulation throughout a drug’s lifecycle. During the afternoon session, the committee will discuss mechanistic model-informed safety evaluation with a focus on drug potential for causing arrhythmias. The Comprehensive in Vitro Proarrhythmia Assay will be discussed as an exemplar.

 

       
Location: Omni Shoreham Hotel The Ballroom 2500 Calvert Street, NW Washington, DC 20008 Related News Links: Not Available
Time: 7:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Ophthalmic Devices Panel of the Medical Devices AdComm and the RC AdComm

Meeting Date: 3/17/17-3/17/17

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Meeting Details:

On March 17, 2017, the committee will discuss and make recommendations regarding the potential risks of misuse of peroxide-based contact lens products.  Specific issues to be discussed include adequate labeling and packaging of these over-the-counter products.

 

       
Location: tbd Related News Links: Not Available
Time: 7:30AM-4:00PM    
Materials:
   
       

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Recent Meetings

Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

Live Meetings

There are no Live Broadcasts available at this time.