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FDA plans mandatory electronic safety reporting (access required)

By: Kimberly Atkins
Published: August 21, 2009

Tags: , ,

New rules proposed by the Food and Drug Administration would amend postmarket safety reporting regulations to require drug and device manufacturers to submit adverse event reports electronically. The move would help tighten federal postmarket safety controls, agency officials said. "Both proposed rules will improve the agency's ability to obtain safety information more quickly, which will help lead ...
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