Generic exclusivity "successful defense" removal is anticompetitive -- NAPM.
This article was originally published in The Tan Sheet
Executive Summary
GENERIC EXCLUSIVITY "SUCCESSFUL DEFENSE" REMOVAL FROM FDA REGULATIONS raises anticompetitive concerns, the National Association of Pharmaceutical Manufacturers said June 23. The NAPM remarks responded to the issuance of an FDA guidance on "180-day Generic Drug Exclusivity Under the Hatch/Waxman Amendments to the Federal Food, Drug & Cosmetic Act" June 22. NAPM plans to submit formal comments within 90 days.
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