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Beyond Reprints for Scientific Information on Unapproved Uses of Medical Products | King & Spalding

Revised Draft FDA Guidance Expands Scope of Permissible Proactive Off-Label Communications This week, FDA published new revised draft guidance, Communications From Firms. ....

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FDA Issues Draft Guidance on Off-label Statements: A New Frontier or Acknowledgement of the Status Quo? | Morgan Lewis

The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific information on unapproved uses of. ....

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FDORA Passage Brings Significant Changes To FDA'S Drug, Device, And Cosmetic Authorities | MoFo Life Sciences

The Consolidated Appropriations Act for 2023 was signed into law on December 29, 2022 and includes the Food and Drug Omnibus Reform Act (FDORA). FDORA authorizes a variety of new and. ....

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Research Roundup: FDA Uses Fall And Winter 2021 To Release Significant New Guidance Governing Hot-Button Life Sciences Research Topics - Food, Drugs, Healthcare, Life Sciences

This Advisory provides an update on several recently issued US Food and Drug Administration (FDA or the Agency) draft guidance documents and advice addressing areas of increased attention. ....

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