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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 9/30/21-9/30/21

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Meeting Details:

Under Topic I, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides (LBP), Division of Bacterial, Parasitic, and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). Also, on September 30, 2021, under Topic II, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 southern hemisphere influenza season. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 8:30AM-3:40PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPatient Engagement Advisory Committee

Meeting Date: 10/6/21-10/6/21

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Meeting Details:

On October 6, 2021, the committee will discuss and make recommendations on the topic ‘‘Medical Device Recalls.’’ Once a medical device is available in the U.S. marketplace and in widespread use, unforeseen problems can sometimes lead to a recall. When a device is defective or potentially harmful, recalling that product—removing it from the market or correcting the problem—is the most effective means for protecting the public. A company may recall a device after discovering a problem on its own, or after FDA raises concerns. In rare cases, FDA may require a company to recall a device. When a device is recalled, FDA reviews the company’s strategy for resolving the problem by assessing the relative degree of risk associated with the product and making sure the strategy effectively resolves the problem with the device. FDA provides transparency and communicates information when the public needs to be alerted to a serious hazard, as well as once the recall has been appropriately resolved. The recommendations provided by the committee will address factors FDA and industry should consider to effectively communicate medical device recall information to patients and the public, including but not limited to content, format, methods used to disseminate the message, and timing of communication. The committee will also consider concerns patients have about changes to their device in response to a recall and will discuss ways patient perspectives could be incorporated in FDA and industry benefit-risk decision making, as well as the healthcare provider and patient decision-making process related to a recalled medical device, including implanted devices. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs Advisory Committee

Meeting Date: 10/7/21-10/7/21

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Meeting Details:

The committee will discuss new drug application (NDA) 215596, for maribavir oral tablets, submitted by Takeda Pharmaceuticals USA, Inc., for the treatment of adults with post-transplant cytomegalovirus infection and/or disease, including infections resistant and/or refractory to ganciclovir, valganciclovir, cidofovir, or foscarnet. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel of the MDAC

Meeting Date: 10/20/21-10/20/21

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Meeting Details:

On October 20, 2021, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the SurgiMend PRS Acellular Bovine Dermal Matrix (SurgiMend PRS ABDM) by Integra LifeSciences Corporation. The proposed Indication for Use, as stated in the PMA, is as follows: SurgiMend PRS Acellular Bovine Dermal Matrix is intended for use as soft tissue support in post-mastectomy breast reconstruction. SurgiMend PRS Acellular Bovine Dermal Matrix is specifically indicated for immediate, two-stage, submuscular, alloplastic breast reconstruction. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 9:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 10/28/21-10/28/21

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Meeting Details:

The committee will discuss new drug application (NDA) 214383, PEPAXTO (melphalan flufenamide) for injection submitted by Oncopeptides AB, approved under 21 CFR 314.500 (subpart H, accelerated approval regulations), in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:30AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the MDAC

Meeting Date: 11/2/21-11/3/21

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Meeting Details:

On November 2, 2021, the committee will discuss and make recommendations on information about the benefit-risk profile of the Endologix AFX endovascular graft system with regards to the risk of Type III endoleaks. FDA requests panel input regarding the totality of data collected on AFX devices and whether further actions are necessary. On November 3, 2021, the committee will discuss and make recommendations on the continued safety and effectiveness of endovascular stent grafts and how to strengthen real-world data collection on long-term performance of the devices, both for currently marketed devices and for future technologies. FDA intends to request panel input on the clinical outcomes that are most relevant to capture in the real world, along with their frequency and duration. Additionally, FDA intends to seek input on data collection platforms, and how to incentivize and optimize real world data collection. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 9:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 11/4/21-11/4/21

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Meeting Details:

The committee will discuss new drug application (NDA) 214812, for carbetocin nasal spray, submitted by Levo Therapeutics, Inc., for the proposed treatment of hyperphagia, anxiety, and distress behaviors associated with Prader-Willi syndrome. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:00AM-6:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 9/17/21-9/17/21

Meeting Details:

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will meet in open session to discuss the Pfizer-BioNTech supplemental Biologics License Application for COMIRNATY for administration of a third dose, or “booster” dose, of the COVID-19 vaccine, in individuals 16 years of age and older. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 8:30AM-3:45PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee Meeting Announcement

Meeting Date: 9/17/21-9/17/21

Meeting Details:

On September 17, 2021, the Pediatric Advisory Committee (PAC) will meet to discuss the pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act of 2003 (Pub. L. 108-155). The PAC will meet to discuss the following products listed by FDA Center: Center for Devices and Radiological Health a. FLOURISH Pediatric Esophageal Atresia Device (humanitarian device exemption) The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:00AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue, and Gene Therapies AdComm

Meeting Date: 9/2/21-9/3/21

Meeting Details:

The CTGTAC committee will meet in open session on both days to discuss the toxicity risks of adeno-associated virus (AAV) vector-based gene therapy products. The discussion topics include oncogenicity risks due to vector genome integration and safety issues identified during preclinical and/or clinical evaluation. On September 2, 2021, in the morning, under session 1, CTGTAC committee will meet to discuss and make recommendations on vector integration and oncogenicity risks. In the afternoon, under session 2, the committee will discuss and make recommendations on hepatotoxicity issues. On September 3, 2021, in the morning, under session 3, the committee will meet to discuss and make recommendations on thrombotic microangiopathy issues. In the afternoon, under session 4, the committee will discuss and make recommendations on non-clinical findings of neurotoxicity, especially related to the dorsal root ganglion toxicity issues. Also, in the afternoon, under session 5, the committee will discuss and make recommendations on clinical findings of neurotoxicity, based on brain MRI studies. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:00AM-6:00PM    
Materials:
   
       

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Past Meetings

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