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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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:
   
       

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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel - - Sponsor: Impulse Dynamics, Inc.

Meeting Date: 12/4/18-12/5/18

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Meeting Details:

On December 4, 2018, the committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the OPTIMIZER SMART Implantable Pulse Generator device, sponsored by Impulse Dynamics (USA), Inc. This first-of-a-kind device is indicated to provide cardiac contractility modulation for class III heart failure patients who are not responding to optimal medical therapy. On December 5, 2018, the committee will discuss and make recommendations regarding issues relating to the emergence of medical devices, which aim to treat hypertension. Currently, clinical studies to evaluate the safety and effectiveness of these devices are progressing. FDA requests panel input regarding the potential indications and labeling for devices intended to treat hypertension and optimal study designs needed to evaluate the potential benefits and risks while considering issues such as medication compliance, patient perspective, and appropriate study controls.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic &Analgesic with DSRM AdComm

Meeting Date: 12/17/18-12/18/18

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Meeting Details:

The committees will provide input and advice on strategies to increase the availability of naloxone products intended for use in the community. The committees will be asked to consider various options for increasing access to naloxone, weighing logistical, economic, and harm reduction aspects and whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death. Because of the potential, significant costs and burdens that may be associated with naloxone co-prescribing (e.g., economic costs to consumers and health systems, adjusting to manufacturing volume growth, drug shortages), the committees will also be asked to consider the potential burdens that may be associated with naloxone co-prescribing for all or some prescription opioid patients.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsPatient Engagement AdComm

Meeting Date: 11/15/18-11/15/18

Meeting Details:

On November 15, 2018, the Committee will discuss and make recommendations on the topic “Connected and Empowered Patients: e-Platforms Potentially Expanding the Definition of Scientific Evidence.” The recommendations will address how FDA can leverage patient-driven platforms, such as social media and registries, to better engage patients and consumers as empowered partners in the work of protecting public health and promoting responsible innovation. Social media and other web platform enablers are facilitating the growth of virtual patient communities. Increasingly, patients and health care consumers are using these platforms to share their health experiences and seek information from other patients and consumers, rather than their health care providers alone. Novel approaches and methodologies are being used to tap into some of these platforms as potentially rich sources of patient-generated health data, which could be used as relevant and reliable real-world evidence. This meeting will help advance FDA’s objective to assure the needs, experiences, and perspectives of patients are included as part of FDA’s deliberations involving the regulation of medical devices and their use by patients. For this meeting, FDA is seeking input from the Committee and the public on whether and how FDA can harness the emerging potential of these patient platforms to better engage patients and consumers as empowered partners in the work of protecting public health and promoting responsible innovation. In addition, FDA is seeking recommendations from the Committee on ways to leverage these platforms to disseminate as well as potentially collect and evaluate health information to and from patients and consumers.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic Drug Products AdComm

Meeting Date: 11/15/18-11/15/18

Meeting Details:

The committee will discuss the assessment of opioid analgesic sparing outcomes in clinical trials of acute pain. The committee will be asked to comment on the trial design and endpoints of these studies and how to determine the clinical relevance of the results.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic & Analgesic with DSRM AdComm - Sponsor: SpecGX Inc.

Meeting Date: 11/14/18-11/14/18

Meeting Details:

The committees will discuss new drug application (NDA) 209774, for an immediate-release oral tablet formulation of oxycodone, which is intended to resist common methods of physical or chemical manipulation and to deter intravenous and intranasal abuse, submitted by SpecGx Inc., for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committees will also be asked to determine whether the Applicant adequately demonstrated that the abuse-deterrent properties of the proposed product are sufficient to include this information in the product label, and whether the product should be approved.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Psychopharmacologic & DSRM AdComm - Sponsor: Sage Therapeutics

Meeting Date: 11/2/18-11/2/18

Meeting Details:

The committees will discuss the efficacy, safety, and benefit-risk profile of new drug application (NDA) 211371, brexanolone 5 mg/mL intravenous injection, submitted by Sage Therapeutics, for the proposed indication of postpartum depression.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Psychopharmacologic & DSRM AdComm - Sponsor: Alkermes Inc.

Meeting Date: 11/1/18-11/1/18

Meeting Details:

The committees will discuss efficacy, safety and risk-benefit profile of new drug application (NDA) 210417 for buprenorphine and samidorphan sublingual tablets, submitted by Alkermes, Inc., for adjunctive treatment of major depressive disorder.

 

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

Meeting Date: 10/24/18-10/25/18

Meeting Details:

Agenda: On both days, the committee will discuss the ``Guidance for Industry: Diabetes Mellitus--Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes' (https://www.fda.gov/downloads/Drugs/Guidances/ucm071627.pdf), and the cardiovascular risk assessment of drugs and biologics for the treatment of type 2 diabetes mellitus.

 

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

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

Live Meetings

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