Recent And Upcoming FDA Advisory Committee Meetings

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

Topic	Advisory Committee	Date	Details
Safety issues associated with over-the-counter analgesic combination products used for upset stomach (i.e., heartburn, nausea, fullness, belching, gas, acid indigestion, and/or sour stomach) and hangover indications under the Internal Analgesic and Antacid monographs; discussion of the hangover indication under the Overindulgence, Internal Analgesic and Stimulant monographs	Nonprescription Drugs; Drug Safety and Risk Management	April 4	Meeting notice (Also see "What’s Next For Antacid/Analgesic OTCs After Negative US FDA Panel?" - Pink Sheet, 4 Apr, 2017.)
Novo Nordisk’s nonacog beta pegol (recombinant human coagulation Factor IX, glycopegylated) for hemophilia B	Blood Products	April 4	Meeting notice (Also see "Novo Hemophilia Drug's Postmarket Monitoring Plan Not Robust Enough – US Panel" - Pink Sheet, 4 Apr, 2017.)
Inspirion Delivery Sciences’ oxycodone immediate-release for management of moderate-to-severe pain where the use of an opioid analgesic is appropriate; committees will discuss the overall risk-benefit profile and whether applicant has demonstrated abuse-deterrent properties that would support labeling	Anesthetic and Analgesic Drug Products; Drug Safety and Risk Management	April 5	Meeting notice (Also see "RoxyBond Gets US Advisory Panel OK For Abuse-Deterrent Claim Despite Excipient Concerns" - Pink Sheet, 5 Apr, 2017.)
Development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections	Antimicrobial Drugs	April 13	Meeting notice