FDA REFORM BILL's OFF-LABEL DATA PROVISIONS DO NOT RESOLVE FREE SPEECH ISSUES IN AGENCY'S CME POLICY, WASHINGTON LEGAL FOUNDATION SAYS IN COURT FILING
This article was originally published in The Gray Sheet
Executive SummaryThe FDA Modernization Act's provisions loosening restrictions on off-label data dissemination do not resolve the free speech issues of the agency's continuing medical education policy, the Washington Legal Foundation (WLF) says in a Nov. 24 memorandum for summary judgment. The filing is the latest action in WLF's suit against FDA, originally Washington Legal Foundation v. Kessler and now WLF v. Friedman and Shalala.
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