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Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

IR Global

9th Circuit Finds That Stromal Vascular Fraction (SVF) Procedures Constitute Treatments As Drugs

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In United States v. California Stem Cell Treatment Center, Inc.[1], the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the...more

Nelson Mullins Riley & Scarborough LLP

FDA Revises Guidance Concerning Scientific Communications to HCPs about Unapproved Uses of Approved/Cleared Medical Products

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The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more

Burr & Forman

Hot Topics in Health Care July 2023  

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Progress of Pre-Submissions for Medical Devices Now Trackable Through CDRH Portal - Medical device manufacturers must submit applications for certain classes of medical devices for approval by the Food and Drug...more

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