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The agency announced the availability of the draft guidance, “Distributing Scientific and Medical Publications on Unapproved New Uses...