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04/22/02

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 12/10/20-12/10/20

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Meeting Details:

The Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
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-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 12/15/20-12/15/20

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Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 207620-S18, for the angiotensin receptor-neprilysin inhibitor, ENTRESTO (sacubitril and valsartan) tablets, submitted by Novartis Pharmaceuticals Corp., for the proposed indication of heart failure with preserved ejection fraction (HFpEF). The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
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 OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 12/16/20-12/16/20

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Meeting Details:

The committee will discuss spironolactone for the proposed treatment of heart failure with preserved ejection fraction (HFpEF), a serious and often fatal condition for which no drug is approved to improve outcomes. The data supporting the new indication are post-hoc analyses of the National Heart, Lung, and Blood Institute (NHLBI) sponsored TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) trial, which nominally failed to meet its primary endpoint. Spironolactone is currently marketed in the US for the treatment of heart failure with reduced ejection fraction, hypertension, primary hyperaldosteronism, and for the management of edema. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
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-1:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 12/17/20-12/17/20

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Meeting Details:

The Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Moderna, Inc., COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years and older. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
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-6:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel of the Medical Devices Advisory Committee Meeting

Meeting Date: 11/9/20-11/9/20

Meeting Details:

On November 9, 2020, the committee will discuss, make recommendations and vote on information regarding the premarket application (PMA) for the VisAbility Micro Insert sponsored by Refocus Group, Inc. The proposed Indication for Use for the VisAbility Micro Insert, as stated in the PMA, is as follows: The VisAbility Micro Insert is indicated for bilateral scleral implantation to improve unaided near vision in phakic, presbyopic patients between the ages of 45 and 60 years of age, who have a manifest spherical equivalent between -0.75D and +0.50 D with less than or equal to 1.00D of refractive cylinder in both eyes, and require a minimum near correction of at least +1.25 D reading add. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
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-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs Advisory Committee

Meeting Date: 11/6/20-11/6/20

Meeting Details:

On November 6, 2020, the committee will discuss biologics license application (BLA) 761178, for aducanumab solution for intravenous infusion, submitted by Biogen Inc., for the treatment of Alzheimer’s disease. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
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: 10:00AM-4:00PM    
Materials:
   
       

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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.