2016 - Webinar on FDA Off-Label Promotion Guidelines

This webinar is intended to help industry better understand FDA's current policy on manufacturers' dissemination of scientific or medical references or texts including information pertaining to off-label (unapproved) new uses of the manufacturers' FDA approved or cleared medical products.
The speaker will walk you through the FDA's current recommended practices.
Areas Covered in the Session :
Applicable Statute(s) and Regulations
Definitions
Regulatory Requirements
FDA's Monitoring and Surveillance Program
FDA's Current Policy on the Issues
Do’s and don’ts of social media techniques in off-label promotion
Implementing Good Medical and Scientific Publication Practices on Off Label Uses
FDA's Untitled Letter Analysis
Common Avoidable Mistakes
How to Prevent Common Mistakes
How to Avoid FDA's Actions
Speaker's Recommendation and Suggestions on PASS-IT Solutions
Conclusion
Who Will Benefit:
CEOs
VPs
Compliance Officers
Attorneys
Regulatory Affairs
Clinical Affairs
Quality Assurance
Research & Development
Consultants
Contractors/Subcontractors
Anyone Interested in the FDA Drug Review and Approval Processes