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Digital Platforms Food and Drug Administration (FDA)

WilmerHale

Recent FDA Guidance Addressing Platform Technologies

WilmerHale on

On May 29, 2024, the U.S. Food and Drug Administration (“FDA”) released draft guidance titled Platform Technology Designation Program for Drug Development. The draft guidance describes the process for requesting and receiving...more

King & Spalding

Beyond Reprints for Scientific Information on Unapproved Uses of Medical Products

King & Spalding on

Revised Draft FDA Guidance Expands Scope of Permissible Proactive Off-Label Communications This week, FDA published new revised draft guidance, Communications From Firms to Health Care Providers Regarding Scientific...more

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