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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 9/24/15-9/24/15

Meeting Details:

On September 24, 2015, the committee will discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization. The system, originally approved in November 2002, under P020014, consists of a delivery system and nickel-containing permanent implants. The implants are placed without a skin incision, through the vagina, within each fallopian tube; they elicit tissue ingrowth, which over time results in tubal occlusion.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 7/10/14-7/11/14

Meeting Details:

On July 10 and 11, 2014, the committee will discuss the safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures, based on available scientific data. The committee will make recommendations regarding the appropriate use, premarket testing, labeling, and other risk mitigations (including the use of containment bags) for these devices. On July 11, 2014, during the afternoon session, the committee will also be asked to discuss the regulatory classification of laparoscopic power morcellator devices when used to cut and extract tissue during gynecologic laparoscopic procedures and to assist FDA in determining the appropriate level of regulatory control necessary for this device type, including discussion of class II (special controls) or reclassification to class III (subject to premarket approval application (PMA)).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel of the Medical Devices

Meeting Date: 9/8/11-9/9/11

Meeting Details:

On September 8 and 9, 2011, the committee will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh used for repair of pelvic organ prolapse. FDA is convening this meeting to seek expert opinion on the risks and benefits of these devices in light of adverse events, e.g., vaginal erosion leading to pelvic pain and dyspareunia, and available information on clinical benefit. The committee will be asked to provide scientific and clinical input on the Agency's proposed premarket and postmarket regulatory strategies for these devices, including [[Page 41508]] reclassification into Class III (premarket approval), labeling improvements and postmarket surveillance studies. The committee will also consider surgical mesh used to treat stress urinary incontinence.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue and Gene Therapies Advisory Committee

Meeting Date: 11/19/10-11/19/10

Meeting Details:

On November 19, the Committee will discuss current FDA recommendations for Testing of Replication Competent Retrovirus (RCR)/Lentivirus (RCL) in Retroviral and Lentiviral Vector Based Gene Therapy Products.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 12/11/08-12/11/08

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for the FC2 Female Condom, sponsored by the Female Health Company. This device is indicated to help prevent HIV/AIDS and unintended pregnancy.

 

       
Location: Gaithersburg Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPostponed: Obstetrics and Gynecology Devices Panel

Meeting Date: 5/16/08-5/16/08

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for the FC2 Female Condom, sponsored by the Female Health Co. This device is indicated to help prevent HIV/AIDS and unintended pregnancy.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 12/13/07-12/14/07

Meeting Details:

On December 13, 2007, the committee will discuss, make recommendations, and vote on a premarket approval application for the Adiana Transcervical Sterilization System, sponsored by Cytyc Surgical Products. This device is indicated to be used as a permanent method for female sterilization. On December 14, 2007, the committee will have a general topic discussion of clinical trial design issues for endometrial ablation devices indicated for pre-menopausal women in whom childbearing is complete and who no longer desire menses (i.e., monthly period). The committee will also hear and discuss a post-approval study update for the ExAblate 2000 System from InSightec, Inc. The system is indicated for ablation of uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 8/29/06-8/29/06

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a non-invasive device for use as a complement to clinical breast examination in asymptomatic women between the ages of 30-39.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 3/28/06-3/28/06

Meeting Details:

On March 28, 2006, the committee will have a general topic discussion of clinical trial design issues for new devices intended to treat symptomatic uterine fibroids.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 3/27/06-3/27/06

Meeting Details:

On March 27, 2006, the committee will discuss, make recommendations, and vote on a premarket approval application for a post surgical adhesion prevention device for use in patients undergoing gynecological laparoscopic surgical procedures.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 10:00AM-5:45PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 6/23/05-6/23/05

Meeting Details:

The committee will hear a presentation on the FDA Critical Path Initiative. The committee will also discuss, make recommendations, and vote on a premarket approval application for a fetal heart monitoring device that, in addition to standard features, is used during labor and delivery to measure, display, and analyze the ST waveform, of the fetal electrocardiogram.

 

       
Location: Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 5/17/05-5/17/05

Meeting Details:

The committee will hear a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design. The committee will also discuss, make recommendations, and vote on a premarket approval application for a spectroscopy-based cervical imaging system intended for use as an adjunct to colposcopy to enhance the identification and selection of biopsy sites.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCancelled - Obstetrics and Gynecology Devices Panel

Meeting Date: 10/25/04-10/25/04

Meeting Details:

The committee will discuss and make recommendations on the type of pivotal study needed to support a premarket approval application for fetal monitors that use neural networks for risk assessment.

 

       
Location: Gaithersburg , MD Related News Links: Not Available
Time: 10:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 6/3/04-6/3/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a system that ablates uterine fibroids using focused ultrasound under the guidance of magnetic resonance.

 

       
Location: HI, GB Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 6/10/03-6/10/03

Meeting Details:

On June 10, 2003, the committee will discuss, make recommendations, and vote on a premarket approval application for an endometrial ablation device.

 

       
Location: Hilton DC North - Gaithersburg Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 7/22/02-7/22/02

Meeting Details:

On July 22, 2002, the committee will hear a presentation on post-market surveillance of vacuum assisted delivery devices. The committee will also discuss, make recommendations, and vote on a premarket approval application for a permanent contraceptive device. Background information, including the agenda and questions for the committee, will be available to the public one business day before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the July 22 session will be posted on July 19, 2002.

 

       
Location: DoubleTree Hotel Rockville, MD Related News Links: Not Available
Time: 8:30AM-5:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 4/22/02-4/22/02

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an intrapartum fetal monitor.

 

       
Location: TBA Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 5/21/01-5/22/01

Meeting Details:

On May 21, 2001, the committee will discuss a supplement to a premarket approval application (PMA) for an intrapartum fetal pulse oximeter. The committee will also hear a presentation on the clinical trial of an intrapartum fundal pressure belt intended to reduce the incidence of operative deliveries. On May 22, 2001, in the morning session, the committee will discuss air and gas emboli associated with operative hysteroscopy. In the afternoon session, the committee will discuss uterine artery embolization.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 1/29/01-1/29/01

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an endometrial ablation device.

 

       
Location: Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices

Meeting Date: 1/24/00-1/25/00

Meeting Details:

On January 24, 2000, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for a fetal pulse oximeter. On January 25, 2000, the committee will discuss a draft guidance document on adhesion barrier products intended for use in pelvic and/or abdominal surgery.

 

       
Location: Gaithersburg Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices

Meeting Date: 10/4/99-10/4/99

Meeting Details:

On October 4, 1999, in the morning session, the committee will discuss issues for new barrier contraceptive devices, such as premarket study design, prescription versus over-the-counter availability, and premarket versus postmarket studies. The following current guidance documents are available as references: (1) Testing Guidance for Male Condoms Made from New Material; (2) Guidance for Industry: Uniform Contraceptive Labeling; and (3) Premarket Testing Guidelines for Female Barrier Contraceptive Devices Also Intended to Prevent Sexually Transmitted Diseases.

 

       
Location: Parklawn Bldg. 5600 Fishers Lane Rockville, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices

Meeting Date: 10/19/98-10/19/98

Meeting Details:

Premarket Approval Application (P980032) Valleylab will summarize its PMA for the VestaTM DUB Treatment System for thermal endometrial ablation.

 

       
Location: FDA Parklawn Building Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Upcoming Meetings

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

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

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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:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

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

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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:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

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

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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:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

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

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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    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

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

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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:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 4/7/16-4/7/16

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Meeting Details:

The committee will discuss new drug application (NDA) 207999, obeticholic acid oral tablets, submitted by Intercept Pharmaceuticals, Inc., proposed for the treatment of primary biliary cirrhosis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Recent Meetings

Meeting 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:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

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

Meeting Details:

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

 

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

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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    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm - PROBUPHINE

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

Meeting Details:

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

 

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

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Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

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