Category: Draft Guidances

Draft Guidances

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FDA Releases Final Guidance on Adaptive Medical Device Study Designs

The FDA has released a final guidance document regarding the benefits, risks, planning, and implementation of adaptive clinical study designs used in medical device development. These study designs—which can change as the data rolls in—can be more efficient than traditional, fixed clinical designs, can provide more responsive treatment for enrolled patients, and can better protect the welfare of the test subjects, according to the guidance document.

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Draft Guidances

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