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Consumer OTC Drugs

OTC switch marketing exclusivity may be facilitated by "paper trail," attorney tells FDLI.

This article was originally published in The Tan Sheet

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Executive Summary

OTC SWITCH MARKETING EXCLUSIVITY AWARDS MAY BE FACILITATED by companies developing a "detailed record" of discussions with FDA regarding clinical trials undertaken toward approval, Washington, D.C. attorney Peter Safir (Kleinfeld, Kaplan, and Becker) suggested at the Food and Drug Law Institute's "Pharmaceutical Update" meeting on May 14.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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