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Joanne Hawana discusses recent actions taken by FDA with regard
to regenerative medicine including clarifying what technologies fit
within the rubric, the announcement of a wholesale review of
polices, and recent enforcement activity.
The content of this article is intended to provide a general
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about your specific circumstances.
The Department of Health & Human Services' Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical...
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.
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape.
In this two-part Triage series, Gina Bertolini, Stephen Page, and Sarah Staples-Carlton discuss an old health care regulatory doctrine that has new relevance in a post-COVID world, where the delivery of care via telemedicine...
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