BioCentury
ARTICLE | Politics & Policy

Aug. 23 P&P Quick Takes: FDA meetings on pediatric safety of OxyContin, Singulair; a vaccine meeting on Chikungunya

August 23, 2019 10:24 PM UTC

FDA panels to discuss pediatric safety of OxyContin, Singulair
On Sept. 26 and 27, a joint meeting of FDA's Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee will discuss pediatric studies and data considerations for pediatric labeling for opioids, including pediatric-focused safety reviews for OxyContin oxycodone hydrochloride extended-release tablets. They will also discuss pediatric-related neuropsychiatric events related to Singulair montelukast.

Chikungunya vaccines advisory committee meeting
FDA's Vaccines and Related Biological Products Advisory Committee will meet Nov. 8 to discuss development of vaccines for Chikungunya virus infections...