FDA Delays Combination Product Safety Reporting Requirements

By David Roza / March 22, 2018 at 8:39 PM
Two new draft guidances on combination products released Tuesday (March 20), one of which extends compliance deadlines and the other which reduces the number of safety reports sponsors have to submit, left one attorney satisfied, but he maintained that companies are still unclear on how to deal with safety reports that come from outside the United States. FDA Commissioner Scott Gottlieb argued the guidances should lead to clear and useful safety reporting from manufacturers. "We want to make sure that...

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