FDA Issues Guidance on Off-Label Use Information

The FDA has updated its guidance on ways in which drug and device manufacturers can distribute peer-reviewed information about off-label uses of medical products. The draft guidance offers a checklist for manufacturers to meet before scientific or medical journals can flow from sales representatives to physicians. The FDA said the information must: 

  • Be published by an organization which has an editorial board with independent expert
  • Be peer-reviewed
  • Be an unabridged reprint
  • Be distributed with approved labeling
  • Be distributed separately from promotional information
  • Include opposing views -- when available -- regarding the unapproved use

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