The United States Food and Drug Administration (FDA) regulates labeling and advertisement for prescription drugs and medical devices among other things. The advertising for nonprescription or over-the-counter (OTC) drugs falls under the jurisdiction of another federal agency.
In pharmaceutical and medical device industry, firms and their representatives distribute or disseminate scientific or medical publications (e.g., journal articles or reference information or texts even including clinical practice guidelines) that discuss off-label uses (unapproved uses) of FDA approved or cleared drugs or medical devices to health care professionals or health care entities.
It is imperative that firms stay in compliance with the FDA’s policy on how to communicate off-label uses of the FDA-approved or cleared medical products (drugs or devices) with the health care professionals.
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
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
PASS-IT Guides
Conclusion
Who Should Attend:
CEOs
VPs
Compliance Officers
Attorneys
Regulatory Affairs
Clinical Affairs
Quality Assurance
R&D
Consultants
Contractors/Subcontractors
Anyone Interested in the FDA Drug Review and Approval Processes