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FDA's Good Reprint Practices Guidance
Pros and Cons of the Proposed Rules for Distribution of Off-Label Information

Medical journals may soon become the pharmaceutical industry's newest physician marketing partner. On Friday, February 15, 2008, the FDA published its draft guidance on "Good Reprint Practices for the Distribution of Medical Journal Articles ... on Unapproved New Uses of Approved Drugs..."

This article summarizes some of issues raised by FDA's proposal that pundits and experts are debating on the Internet, in the press and in official comments submitted to the FDA. It also presents preliminary results of an online survey sponsored by Pharma Marketing News.

Topics and issues covered include:

  • Summary of FDA's Proposed "Good Reprint Practices"
  • Preliminary Survey Results
  • Role of American Enterprise Institute
  • Summary of Section 401 of FDAMA
  • Peer-Review

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PMN72-01
Issue: Vol. 7, No. 2: February 2008
Word Count: 5160

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Vol 7, #2 Contents








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