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Regulatory Focus™ > News Articles > Perspective: FDA’s Draft Good Reprint Practices

Perspective: FDA’s Draft Good Reprint Practices

Posted 01 May 2008

In February 2008, FDA published the draft guidance, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved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. The draft was issued for comment and is intended to provide insight into what conditions make the dissemination of off-label information nonpromotional and acceptable in the agency's view.1


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