FDA PROPOSAL FOR U.S./EUROPEAN MRA MAY INCORPORATE AGENCY THIRD-PARTY DEVICE REVIEW PILOT; AIM WOULD BE TO BREAK STALEMATE OVER PRODUCT APPROVALS
This article was originally published in The Gray Sheet
Executive Summary
A U.S.-European Union device mutual recognition agreement proposal under development by FDA may incorporate the agency's third-party review pilot as a means for including product approvals in the pact.