Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
|
Topic |
Advisory Committee |
Date |
Details |
|
Pediatric-focused safety reviews for various products as mandated by the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act; role of pharmacogenomics in pediatric product development |
Pediatric |
March 6-7 |
|
|
Strain selection recommendations for influenza virus vaccines for the 2017-2018 flu season |
Vaccines and Related Biological Products |
March 9 |
|
|
Premarketing and postmarketing data about the abuse of Endo's Opana ER (oxymorphone extended-release), and abuse of generic extended-release and immediate-release oxymorphone products |
Drug Safety and Risk Management; Anesthetic and Analgesic Drug Products |
March 13-14 |
(Also see "Endo’s Opana ER, Generic Oxymorphone Safety Get US FDA Panel Review" - Pink Sheet, 10 Jan, 2017.) |
|
Strategies, approaches and challenges in model-informed drug development, including use of physiologically-based pharmacokinetic modeling and simulation throughout a drug's life cycle and mechanistic model-informed safety evaluations |
Pharmaceutical Science and Clinical Pharmacology |
March 15 |