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Food and Drug Administration (FDA) › Evidentiary Standards

BakerHostetler

Navigating the FDA’s SIUU Guidance: Key Insights for Pharma and MedTech

BakerHostetler on

On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: Questions and Answers,”...more

McDermott Will & Emery

FDA Issues Draft Guidance on Payor Communications

McDermott Will & Emery on

Shortly after the recently enacted, bipartisan 21st Century Cures Act, which revised and expanded the extent to which specific health care economic information (HCEI) may be disseminated to certain stakeholders, and comes...more

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