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Scientific controversies

This article was originally published in The Tan Sheet

Executive Summary

Should be resolved by sponsors, applicants and manufacturers via "established mechanisms" prior to seeking FDA advisory committee review, FDA says in final rule published in June 16 Federal Register. "FDA recognizes, however, that in appropriate circumstances, review by such an advisory panel or committee may provide FDA with useful advice and recommendations about how the agency may best resolve a controversy," the rule states. The rule complies with the dispute resolution provision of the FDA Modernization Act and was published with a companion proposed rule. The rule would be withdrawn and the usual notice-and-comment rulemaking procedure established for the proposed rule if FDA receives any significant adverse comments...
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