NAVIGATING THE FDA'S GUIDELINES ON OFF-LABEL PROMOTIONS

The FDA has jurisdiction over the labeling and advertising of prescription drugs and medical devices. On the other hand, the responsibility for regulating advertising for non-prescription or over-the-counter drugs falls under another federal agency.

In the pharmaceutical and medical device industry, companies and their representatives often distribute scientific or medical publications containing information on off-label uses (unapproved uses) of FDA approved or cleared drugs or medical devices to healthcare professionals or entities. However, it is important for firms to comply with the FDA's guidelines on how to communicate off-label uses to healthcare professionals.

This webinar is designed to provide insight into the FDA's current policy on the dissemination of scientific or medical references that include information on off-label uses of approved or cleared medical products. Attendees will learn the recommended practices for manufacturers to stay compliant with the FDA's policy on off-label promotion.

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
• 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
• Conclusion

Who Should Attend:

• Quality Assurance Departments
• Regulatory Affairs Departments
• Compliance Officers
• Clinical Affairs Professionals
• Research and Development Departments
• Consultants
• All upper and mid-management professionals
• Contractors/Subcontractors

Course Director: KELLY THOMAS

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.