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FDA clinical evidence of effectiveness guidance released - - very similar to draft.

This article was originally published in The Tan Sheet

Executive Summary

FDA GUIDANCE ON CLINICAL EVIDENCE OF EFFECTIVENESS PUBLISHED as a guide to industry in the May 14 Federal Register along with several other final guidances mandated by the FDA Modernization Act in the week before the six-month deadline. The guidance for human drugs and biologicals was published in draft form in March 1997. The final guidance follows the draft closely in content and language. An exception is the absence of a discussion on efficacy of in vitro diagnostic products that was present in the draft.
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