• June 3-6, 2024
  • San Diego Convention Center, California

Sessions

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Post-Guidance Opportunities and Challenges with Prescription Drug Use-Related Software (PDURS)

Wednesday, June 05, 2024
Breakout Session
AI and Digital Health
24BC
FDA has now released the much-anticipated guidance on PDURS. Issuance of the guidance satisfies a commitment under PDUFA VII and follows on the 2018 announced framework for PDURS that outlined regulatory considerations for software used in conjunction with a drug, typically to support medication adherence. FDA provided some clarity in the guidance, dividing the world into outputs that would be considered part of required labeling, and materials that would be promotional. These new guidance’s have created issues which are fascinating from a regulatory perspective, combining insights on medical device regulation, advertising and promotion, and complex issues of labeling. Panelists should expect a robust discussion of how participants can maximize the value of software and can explore the data needed to satisfy FDA’s expectations. It will also facilitate an exploration of emerging areas for PDURS that extend beyond adherence, potentially improving patient experience and clinical outcomes.
Moderator
Rob Berlin, JD
Head US Regulatory Policy
GSK
Speakers
Eva Temkin, JD
Partner
King & Spalding
Renee Beaver, JD
Director, Commercial Counsel
Otsuka Pharmaceutical
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