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Marketed unapproved drugs workshop

Executive Summary

A public workshop for businesses marketing unapproved drugs will be hosted by FDA Jan. 9. FDA will provide clarification and direction to companies on how to seek drug approval; topics slated for the meeting include NDAs, ANDAs, OTC monographs, application processes, user fees and market exclusivity. The agency 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 Pink Sheet" June 12, 2006, p. 10)...

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