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Drug & Device Law

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The January 6, 2025 Final Guidance On Off-Label Use

By Lisa Baird on January 9, 2025
Photo of Lisa Baird

“Off label use” is a bit of an odd thing.  The FDA does not regulate the practice of medicine, but it does get involved in the labeling of medical devices and pharmaceuticals through the applicable pre-marketing review processes, and those labels identify the use (or uses) intended for that medical product.  That use (or…

Posted in First Amendment, Off-Label Use

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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This blog contains the personal views of the Blogging Team (and of any authors of guest posts) concerning various topics that arise in the defense of pharmaceutical and medical device product liability litigation.

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