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Safety reporting proposed reg

This article was originally published in The Tan Sheet

Executive Summary

FDA will accept comments until Oct. 14 on its proposed rule amending premarketing and postmarketing safety reporting requirements for drugs. Original comment deadline for the reg was July 14, but agency received a request for a 90-day extension, which it deems "appropriate, given the length and complexity of the proposed rule." The 1safety reporting proposed rule, which would encourage more reporting of foreign safety data and premarketing adverse events, was published March 14 (2"The Tan Sheet" March 24, 2003, p. 12)...
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