FDALiveFDALive.com

The World's Leading Source for FDA Broadcasting

Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting Reproductive Health and DSRM AdComm

Meeting Date: 4/18/13-4/18/13

Meeting Details:

The committee will discuss the efficacy and safety of new drug application (NDA) 22219, AVEED (testosterone undecanoate) intramuscular injection, submitted by Endo Pharmaceutical Solutions, Inc., for the proposed indication of replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone. The safety discussion will focus on post marketing reports of oil microembolism in the lungs and potential anaphylactic reactions. In addition to AVEED, other approved testosterone injectable products will be referenced, especially in regard to oil microembolism and potential anaphylactic reactions reported for those products.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsReproductive Health Drugs AdComm

Meeting Date: 3/4/13-3/4/13

Meeting Details:

On March 4, 2013, during the morning session, the committee will discuss new drug application (NDA) 022506, gabapentin 600 milligram (mg) tablets, submitted by Depomed, Inc., for the proposed indication of treatment of moderate to severe vasomotor symptoms due to menopause. During the afternoon session, the committee will discuss NDA 204516, paroxetine mesylate 7.5 mg capsules, submitted by Noven Therapeutics, LLC, for the proposed indication of treatment of moderate to severe vasomotor symptoms associated with menopause.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsReproductive Health Drugs AdComm

Meeting Date: 4/5/12-4/5/12

Meeting Details:

The Committee will discuss the benefits and risks of mirabegron (YM178), under New Drug Application (NDA) 202611, submitted by Astellas Pharma Global Development Inc. for the proposed indication of treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Mirabegron is a beta-3-adrenoceptor (AR) agonist and is a new molecular entity. The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy and safety in the treatment of OAB

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsReproductive Health Drugs;

Meeting Date: 1/20/12-1/20/12

Meeting Details:

The committee will discuss the benefits and risks of new drug application 22- 139, progesterone gel 8%, Columbia Laboratories, Inc., for the proposed indication of "reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.” The uterine cervix is the mouth of the uterus (or womb) leading into the vagina (or birth canal). The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy in the U.S. population.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Reproductive Health Drugs AdComm & the Drug Safety and Risk Management AdComm

Meeting Date: 12/8/11-12/9/11

Meeting Details:

On December 8, 2011, the committees will discuss the benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concern that the risk of venous thromboembolism (blood clots that can break loose and move within the circulatory system) associated with use of these products may be higher compared to oral contraceptives that contain the progestin, levonorgestrel. Drospirenone-containing oral contraceptives for the primary indication of pregnancy prevention include: YASMIN, YAZ (drospirenone/ethinyl estradiol tablets), BEYAZ, SAFYRAL (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), Bayer HealthCare, and the generic equivalents for these products.On December 9, 2011, the committees will discuss the benefits and risks of ORTHO EVRA (norelgestromin/ethinyl estradiol transdermal system), marketed by Janssen Pharmaceuticals, Inc., for the prevention of pregnancy. Specifically, the committees will discuss the possibly increased risk of thrombotic (blood clots) and thromboembolic events (blood clots that can break loose and move within the circulatory system) in users of ORTHO EVRA compared to women who use commonly prescribed birth control pills, as suggested by postmarketing studies.

 

       
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 OptionsReproductive Health Drugs AdComm

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

Meeting Details:

On September 9, 2011, the committees will discuss the benefits and risks of long-term bisphosphonate use for the treatment and prevention of osteoporosis (thinning and weakening of bones that increases the chance of having a broken bone) in light of the emergence of the safety concerns of osteonecrosis of the jaw (jawbone death) and atypical femur fractures (unusual broken thigh bone) that may be associated with the long-term use of bisphosphonates. Bisphosphonates for the treatment and prevention of osteoporosis include: FOSAMAX (alendronate sodium) tablets and solution and FOSAMAX PLUS D (alendronate sodium/cholecalciferol) tablets, Merck & Co., Inc.; ACTONEL (risedronate sodium) tablets, ATELVIA (risedronate sodium) delayed release tablets, and ACTONEL WITH CALCIUM (Copackaged) (risedronate sodium with calcium carbonate) tablets, Warner Chilcott, LLC; BONIVA (ibandronate sodium) tablets and injection, Roche Therapeutics, Inc.; RECLAST (zoledronic acid) injection, Novartis Pharmaceuticals Corp.; and the generic equivalents for these products, if any.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsReproductive Health Drugs

Meeting Date: 6/17/10-6/18/10

Meeting Details:

ON DAY ONE - On June 17, 2010, the committee will discuss new drug application (NDA) 22474, ulipristal acetate tablets, 30 milligrams (mg), by Laboratoire HRA Pharma. Ulipristal is an emergency contraceptive for the proposed indication of the prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. ON DAY TWO - On June 18, 2010, the committee will discuss new drug application (NDA) 22526, flibanserin 100 milligram (mg) tablets, by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed indication of the treatment of hypoactive sexual desire disorder in premenopausal women.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsReproductive Health Drugs - Amgen

Meeting Date: 8/13/09-8/13/09

Meeting Details:

The committee will discuss new biologics license applications (BLAs) 125-320, 125-331, 125-332, and 125-333, proposed trade name PROLIA (denosumab) subcutaneous injection, 60 milligrams (mg), Amgen Inc., for the proposed indications of the treatment and prevention of osteoporosis in postmenopausal women, and the treatment and prevention of bone loss in patients undergoing hormone ablation for prostate or breast cancer. Hormone ablation is a term used to encompass therapies for hormone sensitive breast or prostate cancer administered to decrease sex hormone (estrogen or testosterone) levels. These therapies can result in increased bone loss.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsReproductive Health Drugs

Meeting Date: 9/8/08-9/8/08

Meeting Details:

The committee will discuss new drug application (NDA) 22–242, proposed trade name FABLYN (lasofoxifene tartrate) Tablets, 0.5 milligrams (mg), Pfizer Inc., for the proposed indication of the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

 

       
Location: Hilton Rockville MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsReproductive Health Drugs AdComm

Meeting Date: 1/23/07-1/24/07

Meeting Details:

On January 23 and 24, 2007, presentations and committee discussions will address current issues which influence the consideration for approval of oral and non-oral (i.e., transdermal and intravaginal) hormonal contraceptive drug products. Implantable and injectable hormone products will not be discussed. Issues for discussion will include clinical trial design, expectations for efficacy and safety outcomes, and measures of acceptability of the product to the user, including cycle control.

 

       
Location: FDA - Fishers Lane Rockville, MD Related News Links: Not Available
Time: 8:30AM-6:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsReproductive Health Drugs AdComm

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

Meeting Details:

Adeza announced that its New Drug Application for Gestiva(TM) will be reviewed by the Reproductive Health Drugs Advisory Committee to the FDA on August 29, 2006. Gestiva, a long acting form of a naturally occurring progesterone, is the company's drug candidate to prevent preterm birth in women with a history of preterm delivery.

 

       
Location: FDALive.com Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsReproductive Health Drugs AdComm

Meeting Date: 12/2/04-12/2/04

Meeting Details:

The committee will discuss new drug application (NDA) 21–769, Testosterone Transdermal System (proposed tradename, Intrinsa) by Procter and Gamble, indicated for the treatment of hypoactive sexual desire disorder in surgically menopausal women receiving concomitant estrogen therapy.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsAdvisory Committee for Reproductive Health Drugs

Meeting Date: 12/16/03-12/16/03

Meeting Details:

The committees will consider the safety and efficacy of new drug application 21-045, proposing over-the-counter use of Plan B (levonorgestrel), Women's Capitol Corp., for reducing the chance of pregnancy after unprotected sex (if contraceptive failed or if birth control was not used). The sponsor proposes a 0.75 milligram (mg) tablet taken as soon as possible, but no later than 72 hours after unprotected sex with a second 0.75 mg tablet taken 12 hours after the first tablet.

 

       
Location: Hilton Washington DC North The Ballrooms 620 Perry Pkwy. Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsAdvisory Committee for Reproductive Health Drugs

Meeting Date: 12/15/03-12/15/03

Meeting Details:

The committee will discuss the public health issues, including the safety and potential clinical benefit, associated with combining folic acid and an oral contraceptive into a single combination product.

 

       
Location: The Hilton Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsReproductive Health Drugs Advisory Committee

Meeting Date: 9/29/03-9/30/03

Meeting Details:

Day 1 - The committee will discuss clinical trial design for the development of infertility drugs. Day 2 - Serono’s Luveris

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsReproductive Health Drugs - Pregnancy Labeling Subcommittee

Meeting Date: 9/12/00-9/12/00

Meeting Details:

The subcommittee will meet to identify and discuss those drug and biologic products for which improved pregnancy labeling is critical for: (1) Effective prescribing during pregnancy, or (2) proper counseling of pregnant women who have been inadvertently exposed.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsReproductive Health Drugs - Urology Subcommittee

Meeting Date: 4/10/00-4/10/00

Meeting Details:

The subcommittee will consider the safety and efficacy of new drug application 21-118, UprimaTM (apomorphine HCl tablets, sublingual, TAP Holdings) proposed for use in the treatment of erectile dysfunction.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsReproductive Health Drugs

Meeting Date: 3/28/00-3/29/00

Meeting Details:

On March 28, 2000, the committee presentations and discussions will include the following topics: the status of proposed pregnancy labeling changes, the status of activities related to preclinical assessment of reproductive toxicity, the FDA draft guidance entitled, A Guidance for Industry, Establishing Pregnancy Registries@ (see 64 FR 30041, June 4, 1999, including solicitation for comments [Dockets No. 99D-1541], see also the FDA internet web address www.fda.gov.cder/guidance/index.htm under the heading "Clinical/Medical (draft)"). The committee will also address the methodological and operational challenges in developing and running a pregnancy registry. On March 29, 2000, the committee presentations and discussions will address strategies for monitoring drug risks in pregnant women.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsReproductive Health Drugs

Meeting Date: 10/18/99-10/18/99

Meeting Details:

Presentations and committee discussions will address the following draft FDA guidance documents: (1) Draft guidance for reviewers entitled ``Evaluation of Human Pregnancy Outcome Data'' (see 64 FR 30040, June 4, 1999, including solicitation for comments [Docket No. 99D-1540]), and (2) draft guidance for industry entitled ``Guidance for Industry, Establishing Pregnancy Registries Data'' (see 64 FR 30041, June 4, 1999, including solicitation for comments [Docket No. 99D-1541]). The application and impact of these guidances on drugs reviewed by the Division of Reproductive and Urologic Drug Products will be considered with specific emphasis on drugs used in assisted reproductive technology (infertility treatment regimens). In addition, if revised guidances are available at the time of the meeting, the topics of labeling for non-contraceptive estrogen drug products and the clinical evaluation of estrogen and estrogen/progestin-containing drugs used for hormone replacement therapy in postmenopausal women will be discussed. Any revised draft guidances will be made available to the public near the time of the October 18, 1999, advisory committee meeting.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsReproductive Health Drugs

Meeting Date: 6/3/99-6/3/99

Meeting Details:

The Subcommittee will discuss possible changes to the pregnancy labeling as a result of the September 12, 1997, Part 15 Hearing, the development of various draft guidance documents, and risk communications.

 

       
Location: Holiday Inn Kennedy Grand Ballroom Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsReproductive Health Drugs

Meeting Date: 4/20/98-4/20/98

Meeting Details:

NDA 20-797 Antocin, (Atosiban injection) for use in the management of premature labor from the R.W. Johnson Pharmaceutical Research Institute.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsAdvisory Committee for Reproductive Health Drugs

Meeting Date: 7/19/96-7/19/96

Meeting Details:

The committee will discuss the new drug application for mifepristone for the interruption of early pregnancy.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsAdvisory Committee for Reproductive Health Drugs

Meeting Date: 6/28/96-6/28/96

Meeting Details:

The committee will discuss the safety and efficacy of certain oral contraceptives for postcoital emergency use. Over the years, there has been increasing interest in this use by health care professionals and consumers. This use has been approved in some countries, and physicians have prescribed oral contraceptives for emergency use in the United States, although contraceptives marketed in the United States are not labeled for this use. On November 23, 1994, the Center for Reproductive Law and Policy submitted a citizen's petition requesting FDA to direct sponsors of certain oral contraceptives to amend the labeling and patient package inserts to include information regarding the use of these products for postcoital emergency contraception (Docket No. 94P-0427). FDA denied the petition but determined that it would be appropriate to discuss the scientific issues related to the safety and effectiveness of this use with the Reproductive Health Drugs Advisory Committee to determine whether the data support the use under certain conditions.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsFertility & Maternal Health Drugs

Meeting Date: 6/24/94-6/24/94

Meeting Details:

The committee will discuss: (1) The report of the National Institutes of Health Consensus Development Conference on the effect of corticosteroids for fetal maturation on perinatal outcomes; and (2) a combined contraceptive proposed by Balance Pharmaceuticals, Inc., consisting of a gonadotropin releasing hormone, estrogen, and progestin, provided at presumably safer levels in respect to oncogenic potential.

 

       
Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

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

.

Meeting Details:

The committees will be asked to discuss new drug application (NDA) 208653, benzhydrocodone/acetaminophen oral tablets, submitted by KemPharm, Inc., with the proposed indication of short-term (up to 14 days) management of acute pain. The product has been formulated with the intent to provide abuse-deterrent properties. Benzhydrocodone is a hydrocodone prodrug which, according to the applicant, is rapidly converted into hydrocodone by enzymes in the gastrointestinal tract. The active drugs in this fixed-dose combination are hydrocodone and acetaminophen. The applicant has submitted data to support abuse-deterrent properties for this product. The committees will be asked to discuss whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling, and whether the nasal route of abuse is relevant for combination products made up of hydrocodone and acetaminophen.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 5/24/16-5/25/16

.

Meeting Details:

On May 24th - The committee will discuss the safety and efficacy of new drug application (NDA) 208583 for insulin degludec and liraglutide injection, submitted by Novo Nordisk Inc., for the proposed indication: adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus. On May 25th - The committee will discuss the safety and efficacy of new drug applications (NDAs) 208673 for insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist, and 208471 for lixisenatide injection, a GLP-1 receptor agonist, submitted by Sanofi Aventis c/o Sanofi U.S. Services Inc., proposed for the treatment of adults with type 2 diabetes mellitus.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 5/24/16-5/24/16

.

Meeting Details:

On May 24, 2016, the committee will discuss, make recommendations and vote on information related to the premarket approval application regarding St. Jude Medical's AMPLATZER Patent Foramen Ovale (PFO) Occluder. The AMPLATZER PFO Occluder is a percutaneously delivered permanent cardiac implant for PFO closure. The device is indicated for preventing recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.

 

       
Location: Hiton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 5/24/16-5/25/16

.

Meeting Details:

On May 24th - The committee will discuss the safety and efficacy of new drug application (NDA) 208583 for insulin degludec and liraglutide injection, submitted by Novo Nordisk Inc., for the proposed indication: adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus. On May 25th - The committee will discuss the safety and efficacy of new drug applications (NDAs) 208673 for insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist, and 208471 for lixisenatide injection, a GLP-1 receptor agonist, submitted by Sanofi Aventis c/o Sanofi U.S. Services Inc., proposed for the treatment of adults with type 2 diabetes mellitus.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 6/2/16-6/3/16

.

Meeting Details:

On June 2 and 3, 2016, the committee will discuss recent reports and epidemiologic investigations of nontuberculous mycobacteria (NTM) infections associated with the use of heater-cooler devices during cardiac surgical procedures. FDA is convening this committee to seek expert scientific and clinical opinion related to contamination of heater-cooler devices, associated patient infections, and mitigation strategies based on available scientific information. The committee will make recommendations on: (1) the effectiveness of cleaning and disinfection methods for heater-cooler devices; (2) the amount and type of premarket data and information needed to demonstrate validation of cleaning and disinfection of heater-cooler devices in support of labeling claims and technical instructions; 5 (3) appropriate risk mitigations to be implemented by manufacturers of heater-cooler devices and/or hospital facilities to ensure patient safety during surgical procedures where these devices are used; and (4) appropriate guidelines and/or criteria based on a risk stratification schema for notifying patients who may have already been exposed to NTM during prior cardiac surgeries. Recommendations on these issues will assist FDA in minimizing patient exposure to infections that may result from contaminated heater-cooler devices.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

Meeting Date: 6/7/16-6/7/16

.

Meeting Details:

The committees will be asked to discuss new drug application (NDA) 207975, hydrocodone bitartrate extended-release tablets, submitted by Teva Branded Pharmaceutical Products R&D, Inc., with the proposed indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an extended-release formulation intended to have abusedeterrent properties based on its physicochemical properties. The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

 

       
Location: TBD Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

Meeting Date: 6/8/16-6/8/16

.

Meeting Details:

The committees will be asked to discuss new drug application (NDA) 207621, oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules, submitted by Pfizer, Inc., with the proposed indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an extended-release formulation intended to have abuse-deterrent properties based on the presence of naltrexone, an opioid antagonist, in the formulation. The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

 

       
Location: TBD Related News Links: Not Available
Time: 8:00AM-2:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting-Anesthetic and Analgesic Drug Products AC, the DSRM AC, and the Pediatric AC

Meeting Date: 9/15/16-9/16/16

.

Meeting Details:

The purpose of this public advisory committee meeting is to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation.

 

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

View Meeting Details / News

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs Advisory Committee

Meeting Date: 4/25/16-4/25/16

Meeting Details:

The committee will discuss new drug application (NDA) 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: College Park Marriott Hotel and Conference Center Chesapeake Ballroom 3501 University Boulevard East, Hyattsville, MD 20783 Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel of the Medical Devices AdComm

Meeting Date: 4/20/16-4/20/16

Meeting Details:

The Committee will discuss, make recommendations, and vote on the premarket approval application for the Cartiva Synthetic Cartilage Implant (SCI), sponsored by Cartiva, Inc. The Cartiva Synthetic Cartilage Implant (SCI) is an organic polymer-based biomaterial to mimic biologic cartilage. The device is to be indicated for treatment of degenerative and post-traumatic arthritis in the first metatarsophalangeal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsophalangeal joint.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs Advisory Committee Meeting

Meeting Date: 4/15/16-4/15/16

Meeting Details:

The committee will discuss data submitted by Galderma Laboratories, L.P. to support supplemental new drug application (sNDA) 20-380, for over-the-counter (OTC) marketing of adapalene gel 0.1%. The proposed OTC use is for the treatment of acne and to clear up acne pimples and acne blemishes. The applicant proposes to label the product for 12 years and older. The committee will be asked to consider whether data support an acceptable risk/benefit profile for the nonprescription use of adapalene gel 0.1% by OTC consumers.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 4/12/16-4/12/16

Meeting Details:

On April 12, 2016, 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). See the list of the products in this document to be discussed. In addition, FDA will be providing information on a proposed public advisory committee meeting for September 15 and 16, 2016, on appropriate pediatric development plans for prescription opioid drugs. Prior to the safety reviews and the open public hearing (see later in this section for further information), FDA will present, from approximately 8:30 to 9:30 a.m., a framework of current plans for a 2-day joint meeting of the PAC, the Anesthetic and Analgesic Drug Products Advisory Committee, and the Drug Safety and Risk Management Advisory Committees. Elsewhere in this issue of the Federal Register, FDA is publishing an announcement of this advisory committee meeting to be held on September 15 and 16, 2016, on the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Following the presentation on the proposed framework for the September meeting, there will be an hour of open public hearing from 9:30 a.m. to 10:30 a.m. to provide an opportunity for the public to provide input concerning the topics before the PAC, including the use of opioids for control of severe pain in the pediatric population. To assist with the planning of this advisory committee meeting, FDA is establishing a public docket [Docket No. FDA-2016-N-0584] to receive input on appropriate pediatric development plans for prescription opioid drugs. The docket will remain open following the September advisory committee meeting. Comments about the upcoming September advisory committee meeting should not be submitted to the docket number listed at the top of this Federal Register notice [Docket No. FDA-2016-N-0567]. Please also see the ADDRESSES section of this notice for further docket information. The pediatric-focused safety reviews for the Centers will then occur. The PAC will meet to discuss the following products (listed by FDA Center): Center for Biologics Evaluation and Research (CBER): [cir] FLULAVAL QUADRIVALENT (influenza virus vaccine) [cir] FLULAVAL TRIVALENT (influenza virus vaccine) [cir] FLUZONE QUADRIVALENT (influenza virus vaccine) Center for Drug Evaluation and Research (CDER): [cir] ACIPHEX SPRINKLES (rabeprazole sodium) [cir] SKYLA (levonorgestrel-releasing intrauterine system) [cir] MYCAMINE (micafungin sodium) [cir] NOXAFIL (posaconazole) [cir] PRECEDEX (dexmedetomidine hydrocholoride) [cir] SABRIL (vigabatrim) [cir] SEROQUEL (quetiapine fumarate) and SEROQUEL XR (quetiapine fumarate extended-release) [[Page 8509]] [cir] SKYLA (levonorgestrel-releasing intrauterine system) [cir] SYMBAX (fluoxetine hydrocholoride and olanzapine) [cir] VYVANSE CAPSULES (lisdexamfetamine dimesylate) [cir] XELODA (capecitabine) Center for Devices and Radiological Health (CDRH): [cir] IMPELLA RP SYSTEM (humanitarian use device (HUD)) [cir] LIPSORBER LA-15 SYSTEM (HUD) [cir] MEDTRONIC ACTIVA DYSTONIA THERAPY (HUD) In addition to the agenda items, the PAC will remain in public session over the lunch hour on April 12, 2016, to hear a presentation and provide feedback on an FDA proposal for a risk-based approach to the pediatric-focused safety reviews mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. The working lunch currently is scheduled between approximately 12:30 p.m. and 1:15 p.m.

 

       
Location: DoubleTree Bethesda 8120 Wisconsin Avenue Bethesda, MD 20814 Related News Links: Not Available
Time: 8:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee Meeting

Meeting Date: 4/12/16-4/12/16

Meeting Details:

The committee will discuss new drug application (NDA) 208542 rociletinib tablets, application submitted by Clovis Oncology, Inc. The proposed indication (use) for this product is for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test.

 

       
Location: TBD Related News Links: Not Available
Time: 8:30AM-1:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

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

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: 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.