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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

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Executive Summary

The 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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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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