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Upcoming Meetings
Bone, Reproductive and Urologic Drugs AdComm - Sponsor: AMAG Pharmaceuticals
Meeting Date: 10/29/19-10/29/19
Meeting Details:
The committee will discuss supplemental new drug application (sNDA 021945/S-023#) for MAKENA (hydroxyprogesterone caproate injection, 250 milligrams per milliliter) manufactured by AMAG Pharmaceuticals. In 2011, MAKENA received approval under the accelerated approval pathway (21 CFR part 314, subpart H, and section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) for reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. MAKENA was shown in the preapproval clinical trial to reduce the proportion of women who delivered at less than 37 weeks gestation, a surrogate endpoint that FDA determined was reasonably likely to predict a clinical benefit of preterm birth prevention, such as improved neonatal mortality and morbidity. As required under 21 CFR 314.510, the Applicant conducted a postapproval confirmatory clinical trial to verify and describe clinical benefit. AMAG Pharmaceuticals has disclosed that this completed confirmatory trial did not demonstrate a statistically significant difference between the treatment and placebo arms for the co-primary endpoints of reducing the risk of recurrent preterm birth or improving neonatal mortality and morbidity. The committee will consider the trial's findings and the sNDA in the context of AMAG Pharmaceuticals' confirmatory study obligation.
| Location: | FDA Meeting Room | Related News Links: | Not Available |
| Time: | 8:00AM-5:00PM | ||
| Materials: | |||
- Bone, Reproductive and Urologic AdComm - Sponsor: Agile Therapeutics, Inc.
Meeting Date: 10/30/19-10/30/19
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 | ||
| Materials: | |||
- General Hospital and Personal Use Devices Panel
Meeting Date: 11/6/19-11/7/19
Meeting Details:
On November 6 and 7, 2019, the committee will discuss the topic of industrial ethylene oxide (EtO) sterilization of medical devices and its role in maintaining public health as well as the risks of infection with reprocessed duodenoscopes. Subject matter of the panel meeting will include potential methods and expert assessment of how to reduce EtO emissions to the environment from medical device sterilization processes without compromising assurance of sterility or effective processing of medical devices. The panel will also discuss recommendations to reduce the risk of infection from reprocessed duodenoscopes.
| Location: | Gaithersburg MD | Related News Links: | Not Available |
| Time: | 8:00AM-6:00PM | ||
| Materials: | |||
- Vaccines and Related Biological Products
Meeting Date: 11/8/19-11/8/19
Meeting Details:
On November 8, 2019, the Center for Biologics Evaluation and Research's (CBER) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss and make recommendations on the development of chikungunya vaccines.
| Location: | The Great Room | Related News Links: | Not Available |
| Time: | 8:00AM-5:00PM | ||
| Materials: | |||
- Endocrinologic and Metabolic Drugs AdComm - Sponsor: Boehringer Ingelheim
Meeting Date: 11/13/19-11/13/19
Meeting Details:
The committee will discuss supplemental new drug application (sNDA) 204629/S-020 for empagliflozin oral tablet, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the following proposed indication: As an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.
| Location: | FDA Meeting Room | Related News Links: | Not Available |
| Time: | 8:00AM-5:00PM | ||
| Materials: | |||
- Immunology Devices Panel
Meeting Date: 11/13/19-11/14/19
Meeting Details:
On November 13 and 14, 2019, the committee will discuss the topic of immunological responses to metal-containing products regulated as medical devices. The discussion will focus on metal-containing implants as well as dental amalgam. Implants are medical devices that are placed into a surgically or naturally formed opening of the human body and are intended to remain there after the procedure for an extended period of time (typically, greater than 30 days). For decades, metal-containing implants have been used in a large number of medical specialties including cardiology, orthopedics, dentistry, gastroenterology, and neurology or neurosurgery. Recent postmarket issues with some metal-on-metal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological responses to the implant. These may include local (peri-implant) adverse events and potentially systemic manifestations, which may impact a patient's quality of life and necessitate medical or surgical intervention. While not considered an implant, dental amalgam is included in this discussion because of its potential for patient and user exposure to mercury compounds and some purported similarities in the adverse biological responses and clinical manifestations elicited by some dental amalgams to that of traditional metal implants.
| Location: | Gaithersburg, MD | Related News Links: | Not Available |
| Time: | 8:00AM-6:00PM | ||
| Materials: | |||
- Endocrinologic and Metabolic Drugs AdComm - Sponsor: Amarin Pharma Inc.
Meeting Date: 11/14/19-11/14/19
Meeting Details:
The committee will discuss supplemental new drug application 202057/S-035, for VASCEPA (icosapent ethyl) capsules for oral administration, sponsored by Amarin Pharma Inc., for the following proposed indication: To reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels (135 mg/dL or greater) and other risk factors for cardiovascular disease, based on the results of a clinical study entitled “A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)”
| Location: | FDA Meeting Room | Related News Links: | Not Available |
| Time: | 8:00AM-5:00PM | ||
| Materials: | |||
Recent Meetings
Antimicrobial Drugs AdComm - Sponsor: Shionogi Inc.
Meeting Date: 10/16/19-10/16/19
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 | ||
| Materials: | |||
- Vaccines and Related Biological Products
Meeting Date: 10/9/19-10/9/19
Meeting Details:
On October 9, 2019, the Center for Biologics Evaluation and Research's (CBER) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to hear an overview of the research programs in the Laboratory of Hepatitis Viruses (LIR) and the Laboratory of Vector-Borne Viral Diseases (LVVD), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA. Also, on October 9, 2019, under topic II, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2020 southern hemisphere influenza season.
| Location: | Great Room | Related News Links: | Not Available |
| Time: | 8:00AM-4:00PM | ||
| Materials: | |||
- Pediatric AdComm - Drug Name: Singulair
Meeting Date: 9/27/19-9/27/19
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 | ||
| Materials: | |||
- Pediatric AdComm - Drug Name: OxyContin
Meeting Date: 9/26/19-9/26/19
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 | ||
| Materials: | |||
- Nonprescription Drugs AdComm - Sponsor: GlaxoSmithKline
Meeting Date: 9/18/19-9/18/19
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 | ||
| Materials: | |||
Past Meetings
Below is a listing of all committees. Select a committee to display all meetings available for that committee.
Live Meetings
There are no Live Broadcasts available at this time.
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