Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine
Agency IQ
SEPTEMBER 15, 2023
The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. The two sides saw nearly every finding in a different light.
40 
Let's personalize your content