PMA review goal of decision in 180 days for 75% of applications proposed in FDA's FY 1999 budget.
This article was originally published in The Gray Sheet
PMA REVIEW GOAL OF 180 DAYS FOR 75% OF APPLICATIONS SET BY FDA for fiscal year 1999 (beginning Oct. 1), according to the Clinton Administration's FY 1999 budget proposal. "To speed the review process," FDA resolves to "review and process 75% of new medical device [PMAs] within 180 days, compared to 54% in 1996," the document reads.
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