Drug Name Project Allows Ad Review Opt-Out

摘要

The FDA will make reviews of promotional materials optional for participants in its pilot project to help reduce the potential for medication errors caused by confusion over similar proprietary drug names. The program, described in the concept paper "PDUFA Pilot Project Proprietary Name Review," is supposed to help firms evaluate proposed brand names and submit data to the FDA for review. As a result of comments received at a June 5-6 meeting, the FDA made two substantive changes to the paper, which had been published in draft form. Participation in the part of the program that reviews promotional aspects of proposed drug names has been made optional, and the agency has provided additional information to explain how to review names for OTC drugs.