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FDA Seeks Comments on New Draft Guidance Clarifying Good Reprint Practices

10 March 2014

FDA Alert

In a 3 March 2014 Federal Register notice, the U.S. Food and Drug Administration (FDA or the agency) distributed a revised draft guidance document titled Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices (Draft Guidance) for comment. The Draft Guidance, when finalized, is intended to replace FDA’s January 2009 final guidance titled Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices (2009 Guidance).

Read more: FDA Seeks Comments on New Draft Guidance Clarifying Good Reprint Practices

The team

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