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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 OptionsNonprescription Drugs AdComm - Sponsor: GlaxoSmithKline

Meeting Date: 9/18/19-9/18/19

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Meeting Details:

The committee will discuss data submitted by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, to support new drug application (NDA) 208425, for over-the-counter (OTC) marketing of nicotine oral spray (1 milligram (mg) per spray). The proposed OTC use is to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking. The applicant proposes to label the product for adults 18 years and older. The committee will be asked to consider whether data support an acceptable risk/benefit profile for the nonprescription use of nicotine oral spray (1 mg per spray) by OTC consumers.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm - Drug Name: OxyContin

Meeting Date: 9/26/19-9/26/19

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Meeting Details:

On September 26, 2019, the Pediatric Advisory Committee (PAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee will meet to discuss the pediatric-focused safety review for OxyContin (oxycodone hydrochloride) extended-release tablets, as mandated by the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), and to discuss pediatric data considerations for opioid analgesics labeling and Pediatric Research Equity Act studies for opioids generally, using Opana IR as an example.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm - Drug Name: Singulair

Meeting Date: 9/27/19-9/27/19

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Meeting Details:

On September 27, 2019, the Pediatric Advisory Committee (PAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee will meet to discuss a pediatric-focused safety review of neuropsychiatric events with use of Singulair (montelukast).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-2:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm - Sponsor: Shionogi Inc.

Meeting Date: 10/16/19-10/16/19

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Meeting Details:

The committee will discuss new drug application (NDA) 209445, cefiderocol lyophilized powder for intravenous administration, submitted by Shionogi Inc., for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis due to gram-negative bacteria in patients with limited or no alternative treatment options.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic AdComm - Sponsor: Agile Therapeutics, Inc.

Meeting Date: 10/30/19-10/30/19

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Meeting Details:

The committee will discuss new drug application (NDA) 204017 (levonorgestrel and ethinyl estradiol) transdermal system, submitted by Agile Therapeutics, Inc., for the prevention of pregnancy in women of reproductive potential.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products AdComm - Sponsor: Aimmune Therapeutics, Inc

Meeting Date: 9/13/19-9/13/19

Meeting Details:

On September 13, 2019, the Center for Biologics Evaluation and Research's (CBER) Allergenic Products Advisory Committee (APAC) will meet in open session to discuss and make recommendations on the safety and efficacy of Peanut [Arachis hypogaea] Allergen Powder manufactured by Aimmune Therapeutics, Inc, indicated for treatment to reduce the risk of anaphylaxis after accidental exposure to peanut in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPatient Engagement Advisory Committee

Meeting Date: 9/10/19-9/10/19

Meeting Details:

On September 10, 2019, the Committee will discuss and make recommendations on the topic “Cybersecurity in Medical Devices: Communication That Empowers Patients.” Medical devices are increasingly connected to the internet, hospital networks, and other medical devices to provide features that improve healthcare and increase the ability of healthcare providers to treat patients. These same features may also increase cybersecurity risks. Preserving the benefit of these devices requires continuous vigilance as well as timely and effective communication to medical device users about evolving cybersecurity risks. The recommendations provided by the committee will address which factors should be considered by FDA and industry when communicating cybersecurity risks to patients and to the public, including but not limited to the content, phrasing, the methods used to disseminate the message and the timing of that communication. The recommendations will also address concerns patients have about changes to their devices to reduce cybersecurity risks as well as the role of other stakeholders such as healthcare providers in communicating cybersecurity risks to patients.

 

       
Location: Holiday Inn Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Past Meetings

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