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Risk Management Draft Guidance Department of Health and Human Services (HHS)

Foley & Lardner LLP

FDA & OHRP Draft Guidance: Including Tissue Biopsies in Clinical Trials

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The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more

Jones Day

Vital Signs: Digital Health Law Update | Winter 2024

Jones Day on

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more

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