Terry S. Coleman (Ropes & Gray LLP) has posted Food and Drug Law: History of FDA’s Generic-Drug Policies Before Hatch-Waxman on SSRN. Here is the abstract:
This article is a history of the Food and Drug Administration’s policies governing generic drugs from 1938 until the 1984 enactment of the Drug Price Competition and Patent Term Restoration Act. The article is based on archival documents, oral histories, trade press reports, and other published materials and provides a much more complete and accurate account than has been previously available.
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