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In FDA regulatory matters, companies must carefully choose when to challenge the government, and when to comply. In a recent case, Whoop, the Boston-based wearable maker, has chosen to openly challenge the U.S. Food and Drug...more
Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over...more
Recently, a New York-based dietary supplement manufacturer (and its subsidiaries) issued a nationwide recall of all lots of dietary supplement products manufactured and sold between January 2013-November 2019. Because the...more