FDA and Off-Label Communication – Getting Closer to Truth
Drug & Device Law
NOVEMBER 9, 2023
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 been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. IMS Health Inc. , 357 (2002); United States v. FDA , 119 F.
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