OTC Hangover Remedy Safety On Tap For FDA Advisory Committees

CDER schedules an NDAC and DSRMAC joint meeting while also negotiating with industry stakeholders on a potential proposal for a user fee program to support FDA’s work on finalizing monographs or amending monographs with additional ingredients or indications.

FDA advisory committees will discuss the safety of available OTC analgesic combination products indicated for use as hangover remedies 35 years after the agency began its ongoing evaluation of whether the ingredients are generally recognized as safe and effective for the indication.

The Center for Drug Safety and Evaluation schedules the April 4 joint meeting of the Nonprescription Drugs and the Drug...