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

Important

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

Prices are for evaluation only.

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