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FDA safety reporting proposed reg

Executive Summary

Agency will accept comments until Oct. 14 on its proposed rule amending premarketing and postmarketing safety reporting requirements for drugs and biologics. Original comment deadline for the reg was July 4, but FDA agreed to an extension, "given the length and complexity of the proposed rule," agency says. The 1safety reporting proposed rule was published March 14 (2"The Pink Sheet" March 17, 2003, p. 9)...
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