FDA Off-Label Promotion Guidelines 2019 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 2019 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
