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 The draft guidance offers a checklist for manufacturers to meet before scientific or medical journals can flow from sales representatives to physicians.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
Read the full story