Let's Talk Risk! Podcast
Let’s Talk Risk! brings together MedTech leaders and practitioners for thoughtful conversations on the challenges that shape risk, quality, innovation, and leadership. With 150+ episodes and more than 30K downloads, it helps professionals gain the clarity and confidence to lead through complex decisions. naveenagarwalphd.substack.com
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- StandardSummaries onlyLTR 118: Off-Label Use with Kristen Petersen
Published Aug 8, 2025
Kristen PetersenSummary“When reviewing clinical evidence for off-label use, come up with a plan to systematically address it and build these processes into your SOPs.”In this Let’s Talk Risk! conversation, host Naveen Agarwal and Kristen Petersen discuss the complexities of off-label use in clinical evaluation, emphasizing its significance in the medical device industry. They explore the definitions, examples, and regulatory considerations surrounding off-label use, as well as the importance of documentation an