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The 21st Century Cures Act includes substantial changes to the
FDA's regulation of medical devices. Bethany Hills, Chair of
Mintz Levin's FDA Practice, discusses the impact on digital
health products and the potential evolution of FDA regulation under
Commissioner Scott Gottlieb.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
In August 2023, we published a blog post about the California Office of Health Care Access and Information's ("OHCA") proposed cost and market impact review ("CMIR") regulations under the California Health Care Quality and Affordability Act ("Proposed Regulations").
You only get to incorporate once, and you want to get it right. In this episode, co-hosts Halle Tecco and Michael Esquivel dive deep into the process of incorporation for startups.
Bipartisan legislation moving through the U.S. House and Senate, known as the BIOSECURE Act, could limit the ability of U.S. life sciences companies...
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape.
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