Duration: 60 Minutes


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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

Course Director: DR. DAVID LIM

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.