Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Regulatory news updates.
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Regulatory News In Brief
FDA issues draft guidance on transferring IRB oversight responsibilities. Ethicon Endo-Surgery warns of counterfeit device. More regulatory news.
FDA User Fee Reauthorization Charges Along With Senate Passage
FDA user fee and reform bill sails through Senate on 96-1 vote. House plans to take up its similar legislation this week.
CDRH Prepares For Electronic Recall Submissions; Pre-Market Still A Challenge
Device recall reports may be submitted via FDA’s eSubmitter platform beginning in the coming months. Meanwhile, full-fledged electronic submissions of pre-market device applications are still a ways off.