OTC MONOGRAPH DEVELOPMENT IS ABOUT 30% OF FDA OTC OFFICE WORKLOAD
This article was originally published in The Tan Sheet
Executive Summary
OTC MONOGRAPH DEVELOPMENT IS ABOUT 30% OF FDA OTC OFFICE WORKLOAD, OTC Drug Evaluation Director Michael Weintraub, MD, asserted at a May 24 forum on Rx-to-OTC switches sponsored by Tufts University. Weintraub estimated that approximately 21% of the OTC office resources are taken up by monograph maintenance, 8% by Rx-to-over-the-counter switch applications, 14% by meetings with OTC manufacturers and 5% by congressional inquiries.