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Drug & Device Law
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FDA and Off-Label Communication - Getting Closer to Truth | Drug & Device Law
https://www.druganddevicelawblog.com/2023/11/fda-and-off-label-communication-getting-closer-to-truth.html
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In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here), the FDA has also