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
Results from Pfizer's PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen) trial to determine whether the findings change FDA’s current understanding of the safety of the three nonsteroidal anti-inflammatory drugs; clinical implications of drug interactions between each of the three NSAIDs and aspirin in patients taking aspirin for secondary prevention of cardiovascular disease	Arthritis; Drug Safety and Risk Management	April 24-25	Meeting notice (Also see "Celebrex Likely To Get Label Change Saying CV Risk Is Comparable To Ibuprofen, Naproxen" - Pink Sheet, 25 Apr, 2018.)
SIGA Technologies' tecovirimat, which was developed under the Animal Rule, for treatment of smallpox disease caused by variola virus in adult and pediatric patients	Antimicrobial Drugs	May 1	Meeting notice
Achaogen's plazomicin for treatment of complicated urinary tract infections and blood stream infections in adults	Antimicrobial Drugs	May 2	Meeting notice
InfaCare Pharmaceutical's stannsoporfin injection for treatment of neonates greater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia	Gastrointestinal Drugs; Pediatric	May 3	Meeting notice
Akcea Therapeutics' volanesorsen as an adjunct to diet for treatment of patients with familial chylomicronemia syndrome	Endocrinologic and Metabolic Drugs	May 10	Meeting notice
Drug development for the treatment of children with achondroplasia, including evidence required to establish dose-response, study design, study duration, intended population and endpoints	Pediatric; Endocrinologic and Metabolic Drugs	May 11	Meeting notice (Also see "US FDA Panel's Achondroplasia Drug Development Advice Delayed By Snow" - Pink Sheet, 21 Mar, 2018.)
Approaches for demonstrating effectiveness of group B streptococcus vaccines intended for use in pregnant women to protect the newborn infant; overview of the research program in the Laboratory of Respiratory Viral Diseases, Division of Viral Products in CBER's Office of Vaccines Research and Review	Vaccines and Related Biological Products	May 17	Meeting notice
Insys Development Co.'s buprenorphine sublingual spray for treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate	Anesthetic and Analgesic Drug Products; Drug Safety and Risk Management	May 22	Meeting notice