FDA Finalizes Guidance on Distribution of Reprints Clarifies How Manufacturers Can Hand Out Journal Articles to Docs

JournalsThe FDA recently 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 U.S.”

“There is a more defined line which manufacturers and companies can look at and figure out, ‘how can I make this work for me and how can I make this work for my company,”’ says Erin Reilly Lewis, Esq., counsel with Baker and Daniels in Indianapolis.

This guest article written by Michelle Leppert, Managing Editor, HCPro, Inc., outlines the major provisions of FDA’s reprint guidelines.

Topic headings include:

  • Requirements in the guidance
  • Appropriate information
  • Off-label promotion still prohibited
  • Financial disclosures
  • Industry need for guidance

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Issue: Vol. 8, No. 1: January 2009
Word Count: 1041

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