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Session 9: The ABC’s of SIUU: Recent FDA Revised Draft Guidance
Session Chair(s)
Amy Muhlberg, PHD
, United States
Catherine Gray, PHARMD
Director, Office of Prescription Drug Promotion, OMP, CDER , FDA, United States
This session will discuss the FDA’s recent revised draft guidance “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers”. This guidance addresses stakeholder questions regarding certain communications by firms to health care providers of scientific information on unapproved use(s) of approved/cleared medical products.
Learning Objective :
- Describe the scope and applicability of the SIUU guidance
- Identify the types of SIUU communications
- List the disclosures recommended when disseminating SIUU communications
Speaker(s)
Kathleen David, BSN
Division Director, Division of Promotion Policy, Research, and Operations, OPDP, FDA, United States
Shelby Buettner, JD
Assistant General Counsel and Compliance Officer, Becton Dickinson (BD), United States