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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsCANCELLED: Psychopharmacologic Drugs AdComm

Meeting Date: 7/31/19-7/31/19

Meeting Details:

The committee will discuss new drug application (NDA) 209500, lumateperone tosylate capsules for oral administration, submitted by Intra-Cellular Therapies, Inc., for the treatment of schizophrenia.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Psychopharmacologic & DSRM AdComm - Sponsor: Janssen

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

Meeting Details:

The committees will discuss efficacy, safety and risk-benefit profile of new drug application (NDA) 211243, esketamine 28 mg single-use nasal spray device, submitted by Janssen Pharmaceuticals, Inc., for the treatment of treatment-resistant depression.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Psychopharmacologic & DSRM AdComm - Sponsor: Sage Therapeutics

Meeting Date: 11/2/18-11/2/18

Meeting Details:

The committees will discuss the efficacy, safety, and benefit-risk profile of new drug application (NDA) 211371, brexanolone 5 mg/mL intravenous injection, submitted by Sage Therapeutics, for the proposed indication of postpartum depression.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm

Meeting Date: 3/27/18-3/27/18

Meeting Details:

The committee will discuss new drug application (NDA) 209229, lofexidine hydrochloride, submitted by US WorldMeds, LLC, for mitigation of symptoms associated with opioid withdrawal and facilitation of completion of opioid discontinuation treatment.

 

       
Location: Tommy Douglas Conference Center 10000 New Hampshire Ave Silver Spring, MD 20903 Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs AdComm and the DSRM AdComm

Meeting Date: 11/1/17-11/1/17

Meeting Details:

The committees will discuss new drug application (NDA) 210136, buprenorphine subcutaneous injection, submitted by Braeburn Pharmaceuticals, Inc., for treatment of opioid dependence.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs AdComm and the DSRM AdComm

Meeting Date: 10/31/17-10/31/17

Meeting Details:

The committees will discuss new drug application (NDA) 209819, buprenorphine subcutaneous injection, submitted by Indivior Pharmaceuticals, Inc., for treatment of opioid dependence.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm

Meeting Date: 3/29/16-3/29/16

Meeting Details:

The committee will discuss the specific risk-benefit profile for new drug application (NDA) 207318, NUPLAZID (pimavanserin) 17 milligram (mg) immediate-release, film-coated oral tablets, submitted by Acadia Pharmaceuticals Inc., for the proposed treatment of psychosis associated with Parkinson's disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 2/3/16-2/3/16

Meeting Details:

During the morning session, the committee will discuss cognitive dysfunction in major depressive disorder (MDD). This is an evolving concept and experts in the field have not yet reached consensus as to whether cognitive dysfunction in MDD is a distinct entity. The committee will consider the clinical presentation of cognitive dysfunction in MDD, as well as methods for assessing this condition. During the afternoon session, the committee will discuss new drug application 204447/supplemental new drug application 006, for the effectiveness of vortioxetine for the treatment of cognitive dysfunction in MDD, submitted by Takeda Development Center Americas, Inc.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm - PROBUPHINE

Meeting Date: 1/12/16-1/12/16

Meeting Details:

The committee will discuss new drug application (NDA) 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant, submitted by Braeburn Pharmaceuticals, Inc., on behalf of Titan Pharmaceuticals for the proposed indication of maintenance treatment of opioid dependence.

 

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

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Upcoming Meetings

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products Advisory Committee

Meeting Date: 5/15/20-5/15/20

Meeting Details:

The Center for Biologics Evaluation and Research's (CBER) Allergenic Products Advisory Committee (APAC) will meet in open session to discuss and make recommendations on the safety and efficacy of Peanut (Arachis hypogaea) Allergen Extract manufactured by DBV Technologies, S.A for treatment of patients 4 through 11 years old with a confirmed diagnosis of peanut allergy.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue and Gene Therapies Advisory Committee

Meeting Date: 5/8/20-5/8/20

Meeting Details:

On May 8, 2020, the committee will meet by teleconference. In open session, the committee will hear an overview and updates of research programs in the Tumor Vaccines and Biotechnology Branch (TVBB) and Cellular and Tissue Therapy Branch (CTTB), Division of Cellular and Gene Therapies (DCGT), Office of Tissues and Advanced Therapies (OTAT), CBER, FDA.

 

       
Location: VIRTUAL Related News Links: Not Available
Time: 1:00AM-4:55AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 4/29/20-4/29/20

Meeting Details:

tbd

 

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

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