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The FDA’s and FTC’s Increased Focus on Generic Drug Competition Signals Enhanced Attention to REMS Issues

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Heather Choi, William Lavery, Michael Perry and Jana Seidl published an article, “The FDA’s and FTC’s Increased Focus on Generic Drug Competition Signals Enhanced Attention to REMS Issues” in ABA’s Antitrust Health Care Chronicle in April 2018. This article examines the processes which the FDA requires of generic drug manufacturers in order to obtain approval. Nominated for Concurrences Antitrust Writing Award.

For a full copy of the article, click the title link below.

The FDA’s and FTC’s Increased Focus on Generic Drug Competition Signals Enhanced Attention to REMS Issues

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