FDA drug approval workshop
This article was originally published in The Tan Sheet
Executive Summary
A public workshop for businesses marketing unapproved OTC and prescription drugs will be hosted by FDA Jan. 9 in Rockville, Md., the agency announces in the Nov. 1 Federal Register. FDA will provide clarification and direction to companies on how to seek drug approval, and topics slated for the meeting include NDAs, ANDAs, OTC monographs, application processes, user fees and market exclusivity. Participants must register for the meeting by Nov. 15, which is also the deadline to propose discussion topics for the workshop. FDA says it is convening the meeting because many companies sought clarification following the June 2006 publication of the agency's Marketed Unapproved Drugs-Compliance Policy Guide (1"The Tan Sheet" June 12, 2006, p. 3)...