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From Good Reprint Practices to SIUU Communications: What Firms Need to Know | Sheppard Mullin Richter & Hampton LLP

On October 23, 2023, the Food and Drug Administration (“FDA”) published a new draft guidance, titled Communications From Firms to Health Care Providers Regarding Scientific Information. ....

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FDA 2023 Draft Guidance

FDA 2023 Draft Guidance
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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Draft FDA Guidance Expands Scope of Permissible Proactive Off-Label Communications This week, FDA published new revised draft guidance, Communications From Firms.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FDA Issues Draft Guidance on Off-label Statements: A New Frontier or Acknowledgement of the Status Quo?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The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific information on unapproved uses of.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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FDA Issues Revised Draft Guidance on "Scientific Information on Unapproved Uses Communications" | Foley Hoag LLP

On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs. ....

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