FDA's OTC DRUG ADVERSE REACTION REPORTING SYSTEM PROPOSAL
This article was originally published in The Tan Sheet
Executive Summary
FDA's OTC DRUG ADVERSE REACTION REPORTING SYSTEM PROPOSAL projected for June release, according to the FDA regulatory agenda published in the April 25 Federal Register. The Nonprescription Drug Manufacturers Association has urged FDA to develop a system for requiring adverse drag reaction reports for OTCs based on the agency's current system for prescription drugs marketed without an approved NDA.