Post

Medical Product Communications That Are Consistent With FDA-Required Labeling

This guidance provides information for firms about how FDA evaluates medical product communications that present information not contained in the FDA-required labeling but may be consistent with it. It applies to drugs and devices for humans (including biologics) and animal drugs. The guidance focuses on communications about approved/cleared uses of products while ensuring they remain truthful and non-misleading.

  1. Establish a review process involving qualified medical/scientific, legal and regulatory personnel
  2. Develop a checklist to verify communications are:
    • Consistent with FDA-required labeling
    • Supported by appropriate scientific evidence
    • Include required contextual information and disclosures
  3. Implement procedures to ensure:
    • Accurate representation of study results
    • Clear disclosure of material limitations
    • Inclusion of relevant FDA-required labeling information
  4. Create documentation templates that capture:
    • Evidence supporting communications
    • Rationale for consistency with FDA-required labeling
    • Risk assessment regarding potential for harm
  5. Maintain records of reviews and approvals of communications
  6. Train relevant personnel on requirements and internal procedures
  7. Regularly monitor and update communications based on new safety information

Key Considerations

Clinical testing

  • Clinical study results must be accurately represented and contextualized
  • Material limitations of study design and methodology must be disclosed
  • Unfavorable or inconsistent findings should be disclosed
  • Data from FDA-required labeling should be included for context when relevant

Labelling

  • Communications must be consistent with FDA-required labeling regarding:
    • Indication
    • Patient population
    • Limitations and directions for use
    • Dosing/use regimen and administration
  • Information must be truthful and non-misleading
  • Material limitations must be clearly and prominently disclosed

Safety

  • Communications should not increase potential for harm relative to FDA-required labeling
  • Safety information from FDA-required labeling should be included when relevant
  • Unfavorable safety findings should be disclosed

Other considerations

  • 21 CFR 201.56: Requirements on content and format of labeling for human prescription drug and biological products
  • 21 CFR 202.1: Prescription drug advertisements
  • 21 CFR 807.81: When a premarket notification submission is required

Original guidance

  • Medical Product Communications That Are Consistent With FDA-Required Labeling
  • HTML / PDF
  • Issue date: 2018-06-13
  • Last changed date: 2024-11-12
  • Status: FINAL
  • Official FDA topics: Medical Devices, Drugs, Animal & Veterinary, Biologics, Administrative / Procedural
  • ReguVirta summary file ID: 9bbdb45917b13a4eaf93867608efd6aa
This post is licensed under CC BY 4.0 by the author.