FDALiveFDALive.com

The World's Leading Source for FDA Broadcasting

Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic AdComm - gepirone by Fabre-Kramer Pharma

Meeting Date: 12/1/15-12/1/15

Meeting Details:

The committee will discuss the efficacy and safety data for new drug application (NDA) 21164, gepirone hydrochloride extended-release tablets, submitted by Fabre-Kramer Pharmaceuticals, Inc., for the proposed indication of major depressive disorder.

 

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

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 2/9/16-2/9/16

.

Meeting Details:

The committee will discuss biologics license application (BLA) 125544, for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab), submitted by Celltrion, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; (2) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease; (3) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; (4) reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; (5) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy;1 (6) in combination with methotrexate, reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis; (7) reducing signs and symptoms in patients with active ankylosing spondylitis; (8) reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis; and (9) treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 7:30AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 2/18/16-2/18/16

.

Meeting Details:

The Committee will discuss and make recommendations on clinical trial, postapproval study design, and physician training requirements for leadless cardiac pacemaker device technology. Specifically, the Committee will be asked to make recommendations on the acceptability of adverse event rates in acute and chronic timeframes as well as indications for use for this device type, given availability of other technologies with different adverse event profiles; required training and acceptability of observed learning curves for the new device type and necessary elements for postapproval study collection.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 2/19/16-2/19/16

.

Meeting Details:

The Committee will discuss the premarket application for the DIAM Spinal Stabilization System. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to moderate lumbar degenerative disc disease (DDD) at a single level from L2-L5. DDD is confirmed radiographically with one or more of the following factors: (1) Patients must have greater than 2 millimeters of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach. Amended: The Committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the DIAM Spinal Stabilization System, sponsored by Medtronic Sofamor Danek USA. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have moderate low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to lumbar degenerative disc disease (DDD) at a single symptomatic level from L2-L5. DDD is confirmed radiologically with one or more of the following factors: (1) Patients must have greater than 2 mm of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 2/25/16-2/26/16

.

Meeting Details:

On February 25, 2016, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for ``TOPAS Treatment for Fecal Incontinence,' by ASTORA Women's Health, LLC. The ``TOPAS Treatment for Fecal Incontinence' device is a sling device (mesh) to be implanted around the puborectalis muscle (a muscle that contributes towards the maintenance of fecal continence). The proposed Indication for Use (IFU) for the ``TOPAS Treatment for Fecal Incontinence' device, as stated in the PMA, is as follows: The ``TOPAS Treatment for Fecal Incontinence' is intended to treat women with fecal incontinence (also referred to as accidental bowel leakage) who have failed more conservative therapies. On February 26, 2016, during session I, the committee will discuss and make recommendations regarding the reclassification of urogynecologic surgical mesh instrumentation from class I to class II. The applicable product codes are those related to urogynecologic surgical mesh as follows: OTN and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, multi-incision;' PAG and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, female, multi-incision;' PAH and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, single-incision mini-sling;' OTO and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed;' PAJ and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed;' OTP and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed' and PAI and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed.' Some examples of the means by which these devices perform these functions and their respective IFU/Intended Use (IU) statements are: Urogynecologic surgical mesh instrumentation is used: [cir] IFU/IU: To aid in insertion, placement, fixation, or anchoring of surgical mesh for procedures including transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), treatment of female stress urinary incontinence. Examples of such surgical instrumentation include needle passers and trocars, needle guides, fixation tools, and tissue anchors. The committee, during session II, will discuss and make recommendations regarding the classification of the product code ``LKX' and the associated device classification name, ``Device, Thermal, Hemorrhoids.' The product code LKX represents a category of devices intended to apply controlled cooling and conductive heating to hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Uses an aluminum probe that contains a temperature sensitive element to regulate temperature within 2 degrees (between 37 and 46 degrees centigrade). [cir] IFU/IU: The apparatus is intended to apply controlled, conductive heating to hemorrhoids. Uses a heat applicator inserted into the rectum, applicator contains a battery operated heater, and a sensor which provides temperature control/feedback. [cir] IFU/IU: Intended to provide temporary relief of the symptoms of hemorrhoids through the application of mild heating. Uses speculum-like plastic container containing liquid to cool hemorrhoidal veins. [cir] IFU/IU: Treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins. The committee, during session III, will discuss and make recommendations regarding the classification of the product code ``LRL' and the associated device classification name, ``Cushion, Hemorrhoid.' The product code LRL represents a category of devices intended to temporarily relieve pain and pressure caused by hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Uses an injection molded polypropylene copolymer plastic seat attached to a toilet seat (the product is adjustable and is available in round and elongated versions). [cir] IFU/IU: For the temporary relief from the pain and pressure of hemorrhoids. The device is for external use only. Uses a cushion with an inflatable vinyl exterior and a foam center. An air chamber, when filled, prevents the cushion from compressing the foam. A urethane foam center adds comfort. [cir] IFU/IU: Intended for the home convalescent patient with perineal discomfort. Uses a cushion that contains two internal molded structures that conform to the patient's shape. Exerts ``slight' pressure on hemorrhoid. IFU/IU not required at the time of clearance. The committee, during session IV, will discuss and make recommendations regarding the classification of the product code ``LKN' and the associated device classification name, ``Separator, automated, blood cell and plasma, therapeutic.' The product code LKN represents a category of centrifuge-type devices intended to separate blood components and perform therapeutic plasma exchange for the management of serious medical conditions in adults and children. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments [[Page 940]] became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Utilizes a continuous flow centrifuge (max speed 3000 revolutions per minute) to separate source blood from a subject into blood components. [cir] IFU/IU: May be used to perform therapeutic plasma exchange. [cir] IFU/IU: May be used to perform Red Blood Cell Exchange procedures for the transfusion management of Sickle Cell Disease in adults and children. Uses continuous flow access to a rotating centrifuge to separate blood components. [cir] IFU/IU: May be used to harvest cellular components from the blood of certain patients where the attending physician feels the removal of such component may benefit the patient. [cir] IFU/IU: May be used to remove plasma components and/or fluid selected by the attending physicians.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 3/4/16-3/4/16

.

Meeting Details:

On March 4, 2016, 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 2016-2017 influenza season.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 3/15/16-3/16/16

.

Meeting Details:

On March 15, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System sponsored by Abbott Vascular. The Absorb GT1 BVS System is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length = 24 millimeters (mm)) with a reference vessel diameter of = 2.5 mm and = 3.75 mm. On March 16, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AngelMed Guardian System sponsored by Angel Medical Systems, Inc. The AngelMed Guardian System is an implantable cardiac monitor intended to alert patients to ST segment shifts indicating coronary ischemia. The AngelMed Guardian System is intended for use in patients with prior acute coronary syndrome events, and at risk for recurrent events, to ST segment changes indicating cardiac ischemia.

 

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

View Meeting Details / News

Recent Meetings

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:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPOSTPONED: Peripheral and Central Nervous System Drugs AdComm

Meeting Date: 1/22/16-1/22/16

Meeting Details:

The postponement is due to inclement weather forecasted for the Washington, DC area. The committee will discuss new drug application 206488, eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products AdComm

Meeting Date: 1/21/16-1/21/16

Meeting Details:

The committees will discuss safety and effectiveness data, including challenge study endpoints, for licensure of food allergy immunotherapy products, and the clinical development of aeroallergen immunotherapy products for the prevention of respiratory allergic disease.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-4:00PM    
Materials:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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.