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Past Meetings

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    
Materials:
   
       

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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 OptionsNeurological Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 4/24/14-4/24/14

Broadcasting Live NOW

Meeting Details:

On April 24, 2014, the committee will discuss the current knowledge about the safety and effectiveness of aversive conditioning devices that are intended to deliver a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. FDA is convening this committee to seek clinical and scientific expert opinion on the risks and benefits of certain aversive conditioning devices based on available scientific data and information. The Agency is considering whether to ban aversive conditioning devices that are intended to administer a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. The meeting will concern only devices classified under 21 CFR 882.5235 (aversive conditioning device, class II) that are not self-administered. Devices which deliver a noxious electrical stimulus automatically are not considered to be self-administered devices. Section 516 of the FD&C Act (21 U.S.C. 360f) sets forth the standard for banning devices. Under that provision, in order to ban a device, FDA must make a finding that a device "presents substantial deception or an unreasonable and substantial risk of illness or injury" based on all available data and information. FDA regulations provide additional details about the procedures and standards for banning a device (21 CFR part 895).

 

       
Location: Holiday Inn - Main Ballroom 2 Montgomery Village Ave. Gaithersburg, MD 20879 Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 5/2/14-5/2/14

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Meeting Details:

The committee will discuss data submitted by MSD Consumer Care, Inc., to support a new drug application (NDA) 204804 for over-the-counter (OTC) marketing of montelukast 10 milligram (mg) tablets (proposed trade name SINGULAIR Allergy). The proposed OTC use is "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose.” The applicant proposes to label the product for OTC use in adults 18 years and older. Efficacy and safety data, as well as results of consumer studies, will be discussed. The committee will be asked to consider whether the data support an acceptable risk/benefit profile for the nonprescription use of montelukast tablets by OTC consumers.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsRisk Communication AdComm

Meeting Date: 5/5/14-5/6/14

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Meeting Details:

On May 5-6, 2014, the Committee will meet to discuss methods for identifying the impact and increasing the reach of communications on topics of interest to consumers. The discussion will also address how FDA can evaluate whether its Consumer Updates (http://www.fda.gov/ForConsumers/ConsumerUpdates/default.htm disclaimer icon ) are reaching the targeted population, and whether they are increasing awareness and understanding of the key risk messages. The discussion will also assess whether the communications are having the intended impact on knowledge, behaviors and/or outcomes.

 

       
Location: The Great Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 5/6/14-5/7/14

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Meeting Details:

On May 6, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the RESQCPR System sponsored by Advanced Circulatory Systems, Inc. The RESQCPR System is comprised of two devices: the RESQPOD 16.0 Impedance Threshold Device, and the RESQPUMP Active Compression Decompression CPR Device. These devices are used together during manual cardiopulmonary resuscitation (CPR) in an attempt to enhance venous return to the heart and blood flow to vital organs during CPR to ultimately increase survival and neurologic outcome in patients suffering from out of hospital cardiac arrest. Advanced Circulatory Systems, Inc. has proposed the following indications for use: the RESQCPR System is intended for use in the performance of CPR to increase survival with favorable neurologic function in adult patients with non-traumatic cardiac arrest. On May 7, 2014, during session I, the committee will discuss and make recommendations regarding the classification of membrane lung for long-term pulmonary support systems, one of the remaining preamendment Class III devices regulated under the 510(k) pathway. A membrane lung for long-term pulmonary support refers to the oxygenator component of an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). An ECMO procedure provides assisted extracorporeal circulation and physiologic gas exchange of a patient's blood when an acute (reversible) condition prevents the patient's own body from providing the physiologic gas exchange needed to sustain life. The circuit is comprised of multiple device types, including, but not limited to, an oxygenator, blood pump, cannulae, heat exchanger, tubing, filters, monitors/detectors, and other accessories; the circuit components and configuration (e.g., arteriovenous, veno-venous) may differ based on the needs of the individual patient or the condition being treated. ECMO is currently used for patients with acute reversible respiratory or cardiac failure, unresponsive to optimal ventilation and/or pharmacologic management.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 5/13/14-5/13/14

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Meeting Details:

On May 13, 2014, the committee will discuss and make recommendations regarding the guidance documents for contact lenses and contact lens accessories.

 

       
Location: Holiday Inn Germantown, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 6/17/14-6/17/14

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Meeting Details:

On June 17, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the Maestro® Rechargeable System sponsored by Enteromedics, Inc. The Maestro® Rechargeable System provides VBLOC Therapy. The implantable device is a neuromodulator, which delivers high frequency (5000 Hertz), controllable electrical pulses to the intra-abdominal vagus nerve trunks. The effect of VBLOC therapy is reported to suppress neural signals carried by the vagus nerve trunks, resulting in decreased hunger pangs, decreased digestive enzyme secretion and calorie absorption, and increased satiety. The device consists of implantable electronic device components that deliver VBLOC therapy, and external components that regulate device performance. The proposed indication for use for the Maestro® Rechargeable System, as stated in the PMA, is as follows: The Maestro® Rechargeable System is indicated for use in weight reduction in adult patients with obesity that have a Body Mass Index (BMI) of at least 40 kilograms per square meter (kg/m2), or a BMI of at least 35 kg/m2 with one or more obesity related comorbid conditions, and have failed a more conservative weight reduction alternative.

 

       
Location: FDA Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Adcomm

Meeting Date: 6/25/14-6/25/14

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Meeting Details:

he committee will discuss new drug application (NDA) 206162, olaparib capsules, application submitted by AstraZeneca Pharmaceuticals LP. The proposed indication (use) for this product is as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed ovarian cancer (including fallopian tube or primary peritoneal) with germline BRCA mutation as detected by an FDA-approved test, who are in response (complete response or partial response) to platinum-based chemotherapy.

 

       
Location: FDA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drugs AdComm

Meeting Date: 4/22/14-4/22/14

Meeting Details:

The committee will discuss the safety and efficacy for new drug application 203077, MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, QRxPharma Inc., for the proposed indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. This product represents the first drug combination consisting of two immediate-release opioids.

 

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

Meeting Date: 4/21/14-4/21/14

Meeting Details:

On April 21, 2014, the Pediatric Advisory Committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107–109) and the Pediatric Research Equity Act (Pub. L. 108–155). The PAC will meet to discuss Activa Dystonia Therapy, ADVATE (antihemophilic factor (recombinant)), FAMVIR (famciclovir), INTELENCE (etravirine), KEPPRA (levetiracetam), MAXALT and MAXALT MLT (rizatriptan), NATAZIA (estradiol valerate and estradiol valerate/dienogest), PERTZYE (pancrelipase), PERZISTA (darunavir), REYATAZ (atazanavir), SKLICE (ivermectin), TISSEEL (fibrin sealant), TORISEL (temsirolimus), ULTRESA (pancrelipase), Vertical Expandable Prosthetic Titanium Rib (VEPTR), and VIREAD (tenofovir disoproxil fumarate).

 

       
Location: Bethesda Marriott 5151 Pooks Hill Road Bethesda, MD 20814 Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 4/1/14-4/1/14

Meeting Details:

The committee will discuss new drug application (NDA) 22-472, proposed trade name AFREZZA (TECHNOSPHERE Insulin Inhalation System), 3 unit and 6 unit cartridges for oral inhalation, manufactured by MannKind Corporation. The proposed indication (use) for this application is to improve glycemic control in adult patients with type 1 or type 2 diabetes mellitus.

 

       
Location: College Park Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 3/31/14-3/31/14

Meeting Details:

During the morning session, the committee will discuss new drug applications (NDAs) 205-435 and 205-436, tedizolid phosphate tablets and tedizolid phosphate injection, submitted by Trius Therapeutics, respectively, for the proposed indication of treatment of acute bacterial skin and skin structure infections. During the afternoon session, the committee will discuss NDA 021-883, dalbavancin hydrochloride for intravenous injection, submitted by Durata Therapeutics International B.V., for the proposed indication of treatment of acute bacterial skin and skin structure infections.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 3/27/14-3/27/14

Meeting Details:

The committee will discuss biologics license application 125468, serelaxin injection, submitted by Novartis, as a treatment to improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMolecular and Clinical Genetics Panel

Meeting Date: 3/26/14-3/27/14

Meeting Details:

On March 26, 2014, the committee will discuss, make recommendations and vote on information related to the premarket approval application sponsored by Epigenomics, Inc. for the Epi proColon. The Epi proColon test is a qualitative in vitro diagnostic method for the detection of methylated Septin 9 DNA in plasma derived from patient whole blood specimens. Methylation of the target Septin 9 DNA sequence has been associated with the occurrence of colorectal cancer (CRC). The test is indicated to screen patients for CRC who are defined as average risk for CRC by current screening guidelines. The Epi proColon test is not intended to replace colorectal screening by colonoscopy. Patients with a positive Epi proColon test result should be referred for diagnostic colonoscopy. The Epi proColon test results are intended to be used in conjunction with the physician's assessment of history, other risk factors, and professional guidelines. On March 27, 2014, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Cologuard device, sponsored by Exact Sciences. Cologuard is an in vitro diagnostic device designed to analyze patients' stool for detection of hemoglobin, multiple DNA methylation and mutational markers, and the total amount of human DNA. Cologuard is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer or premalignant colorectal neoplasia. Cologuard is not intended as a replacement for colonoscopy. Cologuard is intended to be used in conjunction with colonoscopy and other test methods in accordance with recognized screening guidelines.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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

Meeting Date: 4/24/14-4/24/14

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Meeting Description:

On April 24, 2014, the committee will discuss the current knowledge about the safety and effectiveness of aversive conditioning devices that are intended to deliver a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. FDA is convening this committee to seek clinical and scientific expert opinion on the risks and benefits of certain aversive conditioning devices based on available scientific data and information. The Agency is considering whether to ban aversive conditioning devices that are intended to administer a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. The meeting will concern only devices classified under 21 CFR 882.5235 (aversive conditioning device, class II) that are not self-administered. Devices which deliver a noxious electrical stimulus automatically are not considered to be self-administered devices. Section 516 of the FD&C Act (21 U.S.C. 360f) sets forth the standard for banning devices. Under that provision, in order to ban a device, FDA must make a finding that a device "presents substantial deception or an unreasonable and substantial risk of illness or injury" based on all available data and information. FDA regulations provide additional details about the procedures and standards for banning a device (21 CFR part 895).


 

       
Location: Holiday Inn - Main Ballroom 2 Montgomery Village Ave. Gaithersburg, MD 20879 Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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