For the second time in the past year . . .

FDA Extends Postmarket Reporting Deadline For Combo Products

By Beth Wang / April 23, 2019 at 2:07 PM
FDA again is extending the period of time during which it will not enforce certain combination product postmarketing safety reporting requirements, the agency announced via an updated guidance on Tuesday (April 23). The extension marks the second time in the past year FDA has pushed out the compliance deadlines for its 2016 postmarket safety reporting final rule, which applies to combination products that are subject to premarket review by FDA. In its Federal Register announcement, FDA says it is...

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