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FDA directed to issue 13 regulatory documents within one year of S 830 passage.

This article was originally published in The Tan Sheet

Executive Summary

FDA WOULD HAVE TO ISSUE 13 REGULATORY DOCUMENTS WITHIN ONE YEAR after the enactment of the Senate FDA reform bill (S 830) based on the version of the measure that passed the Senate Sept. 24 by a vote of 98-2. The FDA Modernization & Accountability Act would require FDA to take action on eight issues within 180 days of the bill's enactment. The agency would have an additional six months to take another five regulatory actions.

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