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Home » RWE Draft Guidance Could be Burdensome to Device Manufacturers, Commenters Note
RWE Draft Guidance Could be Burdensome to Device Manufacturers, Commenters Note
The FDA’s draft guidance describing how device manufacturers can use real-world evidence (RWE) to support regulatory applications is a good start, but needs some refinement to avoid becoming a burden on manufacturers, according to many of the 28 comments posted.