FDA Releases Good Reprint Practices Guidance

On February 15, 2008, FDA announced the release of a draft guidance entitled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.” FDA intends the draft guidance to provide manufacturers with guidelines regarding the dissemination of peer-reviewed scientific journal articles regarding unapproved uses of drugs or medical devices.

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