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FDA Reprint Policy Expands To Clinical Practice Guidelines, Medical Reference Texts

 
• By Brenda Sandburg

FDA has revised, but not loosened, its 2009 final guidance on good reprint practices for distribution of journal articles on unapproved uses of approved drugs and devices.

FDA is revising its guidance about the proper procedures for distributing journal articles about unapproved uses of approved drugs and medical devices to healthcare providers. The new draft document is not much different from the agency’s 2009 final guidance on good reprint practices, but includes new sections on how these practices apply to medical reference texts and clinical practice guidelines.

The agency announced the availability of the draft guidance, “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices,” in a Federal Register notice slated for...

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