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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    
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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 OptionsPediatric Advisory Committee

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

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Meeting Details:

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

 

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

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

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Meeting Details:

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

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel of the Medical Devices Advisory Committee

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

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Meeting Details:

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

 

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

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

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Meeting Details:

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

 

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

Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

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

Meeting Details:

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

 

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

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

Meeting Details:

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

 

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

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

Meeting Details:

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

 

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

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

Meeting Details:

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

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 3/20/14-3/20/14

Meeting Details:

On March 20, 2014, the committee will discuss, make recommendations, and vote on information regarding the humanitarian device exemption (HDE) application for the XVIVO Perfusion System (XPSTM) sponsored by XVIVO Perfusion, Inc. The proposed Indication for Use for the XVIVO Perfusion System, as stated in the HDE, is as follows: The XPSTM is intended to be used with STEEN Solution for flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the function of the lungs can be reassessed for transplantation.

 

       
Location: Holiday Inn, GBurg 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.

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