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Posted 27 August 2019 | By Tarius
Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer information about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner.
13 September – Allergenic Products Advisory Committee
The committee will discuss and make recommendations on the safety and efficacy of Peanut [Arachis hypogaea] Allergen Powder manufactured by Aimmune Therapeutics, Inc, proposed to be 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.
18 September – Nonprescription Drugs Advisory Committee
The committee will discuss a new drug application (NDA) by GlaxoSmithKline Consumer Healthcare Holdings for over-the-counter nicotine oral spray, proposed to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking.
26 September – Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee
The committees 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 (oxymorphone hydrochloride immediate-release tablets) as an example.
27 September – Pediatric Advisory Committee and Drug Safety and Risk Management Advisory Committee
The committees will meet to discuss a pediatric-focused safety review of neuropsychiatric events with use of Singulair (montelukast).
9 October – Vaccines and Related Biological Products Advisory Committee
Under topic I, the Center for Biologics Evaluation and Research’s (CBER) 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. 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.
16 October – Antimicrobial Drugs Advisory Committee
The committee will discuss a new drug application (NDA) for cefiderocol lyophilized powder for IV use, by Shionogi, proposed for treatment of complicated urinary tract infections, including pyelonephritis due to gram-negative bacteria in patients w/ limited or no alternative treatment options.
30 October – Bone, Reproductive and Urologic Drugs Advisory Committee
The committee will discuss Twirla (levonorgestrel and ethinyl estradiol transdermal system), by Agile Therapeutics, proposed for the prevention of pregnancy in women of reproductive potential.
8 November – Vaccines and Related Biological Products Advisory Committee
The committee will discuss and make recommendations on the development of chikungunya vaccines.
Note: More frequent meetings updates are made at the SAC Tracker Upcoming Meetings page, which also lists upcoming dates for additional non-FDA SAC meetings that are convened by HHS. To contact the writer of this article directly, email TariusSACTracker@iqvia.com.
Tags: AdComm, Advisory, Calendar, Committee, Committees, FDA, Meetings, Scientific
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