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FDA Issues Revised Draft Guidance on "Off-Label" Communications to Health Care Providers – Expanded Scope, Yet Limitations Remain | Dechert LLP

The FDA issued Revised Draft Guidance addressing communications by drug and device manufacturers about “off-label” uses of approved products. The Revised Draft Guidance.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Draft FDA Guidance Expands Scope of Permissible Proactive Off-Label Communications This week, FDA published new revised draft guidance, Communications From Firms.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 HCP Drugs Guidance

FDA HCP Drugs Guidance
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FDA Issues Draft Guidance on Off-label Statements: A New Frontier or Acknowledgement of the Status Quo?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The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific information on unapproved uses of.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FDA Issues Revised Draft Guidance on "Scientific Information on Unapproved Uses Communications" | Foley Hoag LLP

On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs.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