Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Topics	Advisory Committee	Date	Details
Gilead's Descovy (emtricitabine/tenofovir alafenamide) for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV	Antimicrobial Drugs	Aug. 7	Meeting notice
Aimmune Therapeutics' peanut [Arachis hypogaea] allergen powder to reduce the risk of anaphylaxis after accidental exposure to peanut in patients ages 4-17 years with a confirmed peanut allergy diagnosis	Allergenic Products	Sept. 13	Meeting notice
Pediatric-focused safety review for Purdue Pharma's OxyContin (oxycodone hydrochloride) extended-release tablets; pediatric data considerations for opioid analgesics labeling; Pediatric Research Equity Act studies for opioids generally, using Opana IR as an example	Pediatric and Drug Safety and Risk Management	Sept. 26	Meeting notice
Pediatric-focused safety review of neuropsychiatric events with use of Singulair (montelukast)	Pediatric and Drug Safety and Risk Mangement	Sept. 27	Meeting notice
Shionogi’s cefiderocol lyophilized powder for intravenous administrationfor the treatment of complicated urinary tract infections (cUTI), including pyelonephritis due to gram-negative bacteria in patients with limited or no alternative treatment options	Antimicrobial Drugs	Oct. 16	Meeting notice
Agile's Twirla (levonorgestrel and ethinyl estradiol transdermal system) for the prevention of pregnancy in women of reproductive potential	Bone, Reproductive and Urologic Drugs	Oct. 30	Meeting notice
Development of chikungunya vaccines	Vaccines and Related Biological Products	Nov. 8	Meeting notice