Good Practices in Responding to Unsolicited Requests for Off-Label Information

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 minutes
Product Description

Implement Good Practices in Responding to Unsolicited Requests for Off-Label Information and Avoid FDA Enforcement Actions

In the pharmaceutical and medical device industry, we often encounter various situations when distributing scientific or medical journal articles, reference texts and clinical practice guidelines that discuss off label uses for FDA-approved drugs or FDA-approved or cleared medical devices marketed in the United States to health care professionals or health care entities. In addition, we also face unsolicited requests for off label information about prescription drugs or medical devices approved or cleared by the FDA.

This audio conference with expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, is intended to discuss good practices in distributing publications on unapproved off label uses and also in responding to public requests for off label information for medical products that have been cleared or approved by the FDA. In particular, it is intended to present FDA-compliant practices in adequately implementing how to distribute publications on unapproved off label uses and how to respond to unsolicited requests for off-label information.

This presentation will provide you with a good opportunity to become aware of and get familiar with FDA’s perspectives on good practices for distributing publications on off-label information or responding to unsolicited requests for off-label information. Dr. Lim will provide his expert insights on how firms should consider and implement good practices compliant with the FDA’s recommendations to avoid enforcement actions.

Session Highlights:

  • Applicable Laws and Regulations
  • Definitions
  • Differences Between Off Label and On Label Uses
  • How to Distribute Publications on Unapproved New Uses
  • How to Communicate Off-Label Information
  • FDA’s Current Thinking And Perspectives
  • Best Practices for Responding to Unsolicited Requests for Unapproved Uses
  • PASS-IT Recommendations: Dos and Don’ts

Who Should Attend

  • Healthcare industry: Drugs, biologics, medical devices/IVDs, combination products, etc.
  • Compliance Officers
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Laboratory Personnel
  • R&D Professionals
  • Consultants
  • Contractors/Subcontractors
  • Other professionals interested in the topic

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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