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
Alkermes' buprenorphine/samidorphan sublingual tablets for adjunctive treatment of major depressive disorder	Psychopharmacologic Drugs/Drug Safety and Risk Management	Nov. 1	Meeting notice (Also see "Alkermes' Depression Drug Likely Needs Another Trial After Crushing US Advisory Cmte. Vote" - Pink Sheet, 1 Nov, 2018.)
Sage Therapeutics' brexanolone 5mg/mL intravenous injection for postpartum depression	Psychopharmacologic Drugs/Drug Safety and Risk Management	Nov. 2	Meeting notice (Also see "Sage's Postpartum Depression Drug Brexanolone Faces Loss-Of-Consciousness Questions" - Pink Sheet, 31 Oct, 2018.)
Overview of the research program in the Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review	Vaccines and Related Biological Products	Nov. 8	Meeting notice
SpecGx LLC's oxycodone immediate-release tablets, intended to resist common methods of physical or chemical manipulation and to deter intravenous and intranasal abuse, for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate	Anesthetic and Analgesic Drug Products/Drug Safety and Risk Management	Nov. 14	Meeting notice
Assessment of opioid analgesic sparing outcomes in clinical trials of acute pain	Anesthetic and Analgesic Drug Products	Nov. 15	Meeting notice
Strategies to increase the availability of naloxone products intended for use in the community, including co-prescribing with opioid prescriptions	Anesthetic and Analgesic Drug Products/Drug Safety and Risk Management	Dec. 17-18	Meeting notice