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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs & DSRM

Meeting Date: 10/16/14-10/16/14

Meeting Details:

The committees will discuss the risk of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate) tablets, NDA 21928, Pfizer, Inc., and discuss options for addressing this risk.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 3/21/13-3/21/13

Meeting Details:

On March 21, 2013, the committee will discuss new drug application (NDA) 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant, submitted by Titan Pharmaceuticals, Inc., and its safety and efficacy for the proposed indication of maintenance treatment of opioid dependence.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 12/12/11-12/12/11

Meeting Details:

The committee will discuss safety and efficacy issues with new drug application (NDA) 022549, ADASUVE (loxapine) inhalation powder, Alexza Pharmaceuticals, Inc., for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Particular issues for discussion are concerns regarding pulmonary safety.

 

       
Location: The Marriott Inn and Conference Center, University of Maryland University College Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm

Meeting Date: 9/16/10-9/16/10

Meeting Details:

The committee will discuss the available safety and efficacy data for supplemental new drug application (sNDA) 21897/015, VIVITROL (naltrexone for extended-release injectable suspension), sponsored by Alkermes, Inc., for the treatment of opioid dependence.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm

Meeting Date: 7/30/09-7/30/09

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 22117, proposed trade name SAPHRIS (asenapine maleate) sublingual tablets, Organon, a part of Schering-Plough Corp., for the following indications: (1) Acute treatment of schizophrenia in adults and (2) acute treatment of manic or mixed episodes of bipolar I disorder in adults.

 

       
Location: Hilton Silver Spring MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 6/9/09-6/10/09

Meeting Details:

On both days, the committee will discuss safety and efficacy issues for the following new drug applications (NDAs): (1) NDA 20-639/S-045 and S-046: SEROQUEL (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, for the acute treatment of schizophrenia in adolescents from 13 to 17 years of age, and the acute treatment of bipolar mania in children from 10 to 12 years of age and adolescents from 13 to 17 years of age; (2) NDA 20-825/S-032: GEODON (ziprasidone hydrochloride) Capsules, Pfizer Inc., for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in children and adolescents ages from 10 to 17 years of age; and (3) NDA 20-592/S-040 and S-041: ZYPREXA (olanzapine) Tablets, Eli Lilly and Co., for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the acute treatment of schizophrenia in adolescents. The committee will be asked to vote on whether or not these products have been shown to be effective and acceptably safe for these pediatric indications.

 

       
Location: Marriott Conference Centers Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm

Meeting Date: 4/7/09-4/8/09

Meeting Details:

On April 7, 2009, the committee will discuss safety and efficacy issues of new drug application (NDA) 20644, sertindole (Serdolect) tablets, Lundbeck USA, proposed for the treatment of schizophrenia. On April 8, 2009, the committee will discuss safety and efficacy issues of supplemental new drug applications (sNDAs) 22047/S010/S011/S012, quetiapine b6 maleate (Seroquel XR), Astra Zeneca Pharmaceuticals LP, proposed for the treatment of major depressive disorder and 22047/S014/S015, Seroquel XR (quetiapine maleate), Astra Zeneca Pharmaceuticals LP, proposed for the treatment of generalized anxiety disorder. Particular safety issues for discussion on April 8, 2009, regarding the Seroquel XR applications are concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia.

 

       
Location: Hilton Washington DC/Silver Spring The Ballrooms Silver Spring, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm

Meeting Date: 2/6/08-2/6/08

Meeting Details:

The committee will discuss new drug application (NDA) 22-173, ZYPREXA ADHERA (olanzapine pamoate depot) long acting intramuscular injection (210 milligrams (mg), 300 mg, and 405 mg per/vial), Eli Lilly and Co., for the treatment of schizophrenia. A particular safety concern for discussion is the occurrence of severe somnolence in some patients who are administered this depot formulation of olanzapine.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 12/13/06-12/13/06

Meeting Details:

The committee will discuss the results of the FDA ongoing meta-analysis of suicidality data from adult antidepressant trials.

 

       
Location: Hilton Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm

Meeting Date: 9/7/06-9/7/06

Meeting Details:

*** Meeting Cancelled *** On September 7, 2006, the committee will discuss NDA 21- 992, desvenlafaxine succinate (DVS 233), ER tablets, Wyeth Pharmaceuticals, proposed indication for treatment of major depressive disorder.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm

Meeting Date: 3/23/06-3/23/06

Meeting Details:

The committee will discuss new drug application (NDA) 20-717, S-019, PROVIGIL (100 milligrams (mg), 200 mg, 85 mg, 170 mg, 255 mg, 340 mg, and 425 mg) Tablets, Cephalon, Inc.; the proposed indication is for the treatment of attention deficit hyperactivity disorder (ADHD).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm

Meeting Date: 12/2/05-12/2/05

Meeting Details:

The committee will discuss new drug application (NDA) 21-514, proposed trade name METHYPATCH (Methylphenidate) Tdp, (Methylphenidate Transdermal System), Noven Pharmaceuticals, proposed indication for the treatment of attention deficit hyperactivity disorder (ADHD).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm

Meeting Date: 10/25/05-10/26/05

Meeting Details:

On October 25, 2005, the committee will discuss issues and questions pertinent to the need for longer-term efficacy data for proposed drug treatments for chronic psychiatric disorders, and issues and questions pertinent to optimal study designs for obtaining valid information about longer-term benefits of drug treatment. On October 26, 2005, the committee will discuss the question of whether or not dietary restrictions would be needed for the 20 milligrams (mg) dose for proposed trade name EMSAM (selegiline transdermal system) (new drug applications (NDAs): NDA 21-336, short-term claim, and NDA 21-708, longer-term claim, Somerset Pharmaceuticals), for the treatment of major depressive disorder.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Psychopharmacologic Drugs & Pediatric Advisory Committee

Meeting Date: 9/13/04-9/14/04

Meeting Details:

The Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committee will discuss reports of the occurrence of suicidality (both suicidal ideation and suicide attempts) in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder and other psychiatric disorders. Preliminary risk data based on the classification of these adverse event reports by the pharmaceutical sponsors of these products were presented at the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee held on February 2, 2004. Since that meeting, experts in pediatric suicidality, assembled by Columbia University, have independently classified these reported events, and FDA has conducted an analysis of these data. On September 13 and 14, 2004, the committees will consider the results of FDA’s analysis of these independently classified events and will consider what further regulatory action may be needed with regard to the clinical use of these products in pediatric patients. The committees will also consider further research needs to address questions on this topic.

 

       
Location: Holiday Inn Versailles Ballrooms Bethesda, MD Related News Links: Not Available
Time: 8:00AM-6:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm

Meeting Date: 6/16/03-6/16/03

Meeting Details:

On June 16, 2003, the committee will discuss the white blood cell (WBC) monitoring schedule for patients being treated long-term with clozapine. Currently, the WBC monitoring schedule is weekly for the first six months of continuous therapy, and biweekly thereafter. The committee will consider the question of whether the frequency of WBC monitoring can be diminished further following some period of biweekly monitoring.

 

       
Location: Marriott Gaithersburg, Md. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs

Meeting Date: 11/4/02-11/4/02

Meeting Details:

The committee will discuss on Novartis Pharmaceuticals drug Clozaril. This application is proposed for treatment of suicidality in patients with schizophrenia disorders.

 

       
Location: GHOL Related News Links: Not Available
Time: 8:00AM-4:30AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 5/10/02-5/10/02

Meeting Details:

The Merck KGaA subsidiary filed the NDA 21-431 a drug for the treatment of alcohol addiction, acamprosate has been approved in most major European markets as well as in Latin America and Australia. It is marketed under the brand name Campral.

 

       
Location: Holiday Inn in Bethesda, Md. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 2/14/01-2/15/01

Meeting Details:

On February 14-15, 2001, FDA Psychopharmacologic Drugs Advisory Committee will review intramuscular formulations of Lilly's Zyprexa (olanzapine) and Pfizer's Zeldox (ziprasidone) for use in schizophrenia. Zyprexa, which is already marketed in an oral formulation, will be reviewed on Feb. 14. Zeldox, which is "approvable" at FDA in an oral formulation, will be reviewed on the second day.

 

       
Location: MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 7/19/00-7/19/00

Meeting Details:

At a July 19, 2000 meeting, FDA's Psychopharmacologic Drugs Advisory Committee will review Pfizer's Zeldox for management of psychotic disorders.

 

       
Location: Holiday Inn Bethesda, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 3/9/00-3/9/00

Meeting Details:

Dementia Drug Development Guidelines The Psychopharmacologic Drugs Advisory Committee will discuss drug development for Alzheimer's and other dementias. The panel will address the problem of how to identify, define, and name clinical entities that fall under the dementia category in order to prevent misleading labeling. The committee meeting will be broadcast live by videoconferencing, webcast and telephone link ups. In addition, videotapes will be available for delivery the day after the meeting.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs

Meeting Date: 11/3/99-11/3/99

Meeting Details:

The committee will discuss the safety and efficacy of Prozac (fluoxetine hydrochloride, Lilly), to treat premenstrual dysphoric disorder.

 

       
Location: Hilton Gaithersburg, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs

Meeting Date: 10/7/99-10/8/99

Meeting Details:

In October 7, 1999, the committee will consider the safety and efficacy of new drug application(NDA)supplement 20-592/S-009, Zyprexa (olanzapine, Lilly), proposed to treat psychosis associated with dementia. On October 8, 1999, the committee will consider the safety and efficacy of NDA supplement 19-839/S-026, Zoloft (sertraline hydrochloride, Pfizer Pharmaceuticals) proposed to treat posttraumatic stress disorder.

 

       
Location: Holiday Inn Versailles Ballrooms I and II 8120 W Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 12/4/97-12/4/97

Meeting Details:

On December 4, 1997, the committee will hear presentations from the Institute of Medicine on the marketed product Halcion (triazolam, Pharmacia and Upjohn Co.).

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 7/14/97-7/14/97

Meeting Details:

The committee will consider proposals to reduce the frequency of required white blood cell count monitoring for Clozaril (clozapine), new drug application (NDA) 19-758, Sandoz Pharmaceutical Corp.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 7/15/96-7/15/96

Meeting Details:

The committee will discuss the safety and effectiveness of Serlect (sertindole), new drug application (NDA) 20-644, Abbott Laboratories, for use in the treatment of psychotic disorders.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 10/16/95-10/16/95

Meeting Details:

The committee will discuss the safety and effectiveness of REMERON (mirtazapine), new drug application (NDA) 20-415, Organon, Inc., for use in the treatment of depression.-

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs

Meeting Date: 7/24/95-7/25/95

Meeting Details:

On July 24 and 25, l995, the committee will discuss issues in the design and conduct of studies involving antipsychotic drugs.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs

Meeting Date: 2/6/95-2/6/95

Meeting Details:

The committee will discuss the safety and effectiveness of Depakote tablets (divalproex sodium tablet), new drug application (NDA) 20-320, Abbott Laboratories, for use in the treatment of manic episodes associated with bipolar disorder.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue and Gene Therapies and ODAC

Meeting Date: 4/29/15-4/29/15

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Meeting Details:

The committees will discuss talimogene laherparepvec, Amgen, Inc., biologics license application (BLA) 125518, an oncolytic immunotherapy for the treatment of patients with injectable regionally or distantly metastatic melanoma.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEar, Nose, and Throat Devices Panel

Meeting Date: 4/30/15-5/1/15

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Meeting Details:

On April 30, 2015, the committee will discuss and make recommendations regarding the classification of Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, and Vestibular Analysis Apparatuses. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Hearing Protectors are currently regulated under the heading, “Protector, Hearing (Insert),” Product Code EWD, as unclassified under the 510(k) premarket notification authority. Circumaural Hearing Protectors are currently regulated under the heading, “Protector, Hearing (Circumaural),” Product Code EWE, as unclassified under the 510(k) premarket notification authority. Middle Ear Inflation Devices are currently regulated under the heading, “Device, Inflation, Middle Ear,” Product Code MJV, as unclassified under the 510k) premarket notification authority. Tactile Hearing Aid Devices are currently regulated under the heading, “Hearing Aid, Tactile,” Product Code LRA, as unclassified under the 510(k) premarket notification authority. Vestibular Analysis Apparatuses are currently regulated under the heading, “Apparatus, Vestibular Analysis,” Product Code LXV, as unclassified under the 510(k) premarket notification authority. FDA is seeking committee input on the risks, safety and effectiveness and the regulatory classification of Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, and Vestibular Analysis Apparatuses. On May 1, 2015 the committee will discuss key issues related to a potential pre- to post-market shift in clinical data requirements for modifications to cochlear implants in pediatric patients. These issues are categorized into three broad areas for discussion: 1. Cochlear implant changes (e.g. sound processing features, patient characteristics) that may be suitable for this pre- to post-market shift in clinical data requirements. 2. Appropriate premarket clinical data requirements to support pre- to post-market shift (e.g. leveraging clinical data from adults and/or older children.) 3. Clinical study design considerations (e.g. study endpoints and test metrics, subject characteristics) for post market studies to confirm safety and effectiveness and inform future labeling.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Adcomm

Meeting Date: 5/12/15-5/12/15

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Meeting Details:

The committee will discuss new drug application (NDA) 206038, lumacaftor/ivacaftor combination tablets for oral use, submitted by Vertex Pharmaceuticals, proposed for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 4/17/15-4/17/15

Meeting Details:

On April 17, 2015, the committee will discuss the current knowledge regarding the conduct of clinical studies and evaluation of clinical study data for flow diverter technology. FDA is convening this committee to seek expert opinion on scientific and clinical considerations relating to the study design and existing clinical studies, for flow diverter technology indicated for the neurovasculature.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 4/15/15-4/15/15

Meeting Details:

The committee will discuss new drug application New Drug Application 204958, cangrelor injection, submitted by The Medicines Company, for the proposed indication of reduction of thrombotic cardiovascular events including stent thrombosis (events related to blood clots in a stent, a device inserted to keep the artery open) in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). PCI refers to the opening of narrowed blood vessels supplying the heart muscle by a balloon inserted through an artery puncture with or without a stent.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 4/14/15-4/14/15

Meeting Details:

During the morning session, the committee will discuss the results of the cardiovascular outcomes trial (CVOT), Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus, for new drug application (NDA) 22350, Onglyza (saxagliptin) and NDA 200678, Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets manufactured/marketed by AstraZeneca AB. During the afternoon session, the committee will discuss the results of the CVOT, Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care, for NDA 22271, Nesina (alogliptin); NDA 022426, Oseni (alogliptin and pioglitazone); and NDA 203414, Kazano (alogliptin and metformin) tablets marketed by Takeda Pharmaceutical U.S.A., Inc. Saxagliptin and alogliptin are dipeptidyl peptidase-4 (DPP4) inhibitors, both indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Both CVOTs were submitted in accordance with the 2008 FDA Draft Guidance, “Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 7:30AM-5:15AM    
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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

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