FDA Off-Label Promotion Guidelines 2019

Topics

• 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

Who should Attend

• 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