FDA Finalizes Guidance on Good Reprint Practices

On January 12, 2009, the United States Food and Drug Administration (“FDA”) finalized its 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 (“GRP Guidance”). While not legally binding, the GRP Guidance provides the agency’s current thinking about the distribution of journal articles and reprints by drug or medical device manufacturers and representatives and differs only slightly from the draft guidance FDA released for comment in February, 2008. We summarize the agency’s most significant recommendations below; any substantive change from the 2008 draft guidance has been bolded.


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