FDA Off-Label Promotion Guidelines


FDA Off-Label Promotion Guidelines is a webinar that covers topics such as:

  • Definitions
  • Applicable Statute(s) and Regulations
  • FDA’s Monitoring and Surveillance Program
  • Regulatory Requirements
  • Implementing Good Medical and Scientific Publication Practices on Off Label Uses
  • FDA’s Current Policy on the Issues
  • Common Avoidable Mistakes
  • FDA’s Untitled Letter Analysis
  • How to Avoid FDA’s Actions
  • How to Prevent Common Mistakes
  • Conclusion
  • PASS-IT Guides

FDA Off-Label Promotion Guidelines is intended for:

  • VPs
  • CEOs
  • Attorneys
  • Compliance Officers
  • Clinical Affairs
  • Regulatory Affairs
  • R&D
  • Quality Assurance
  • Contractors/Subcontractors
  • Consultants
  • Anyone Interested in the FDA Drug Review and Approval Processes

Future Events

FDA Off-Label Promotion Guidelines 2020


Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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