Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming FDA advisory committee meetings and a summary of topics covered.
|
Topic |
Advisory Committee |
Date |
|
Pediatric-focused safety reviews of various products as mandated by the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act |
Pediatric |
April 21 (rescheduled from March 3) |
|
QRxPharma Inc.’s MoxDuo (morphine sulfate/oxycodone hydrochloride) capsules for management of moderate to severe acute pain where the use of an opioid analgesic is appropriate |
Anesthetic and Analgesic Drug Products |
April 22 |
|
MSD Consumer Care Inc.’s NDA for over-the-counter sale of Singulair Allergy (montelukast 10 mg tablets) for use by adults to temporarily relieve the following symptoms due to hay fever or other upper respiratory allergies: nasal congestion; runny nose; itchy, watery eyes; sneezing; itching of the nose |
Nonprescription Drugs |
May 2 |
|
Methods for identifying the impact and increasing the reach of communications on topics of interest to consumers; how FDA can evaluate whether its Consumer Updates are reaching the targeted population, and whether they are increasing awareness and understanding of the key risk messages; whether communications are having the intended impact on knowledge, behaviors and/or outcomes |
Risk Communications |
May 5-6 |