This episode of Ropes & Gray's podcast series Non-binding Guidance examines the regulatory landscape for drug compounding and how it has evolved over the last 10 years since a.
This installation of Ropes & Gray s podcast series
Non-binding Guidance focuses on FDA regulatory
developments in the area of artificial intelligence
( AI ) and machine learning. AI and machine learning
represent a rapidly growing frontier in digital health, with
applications ranging from medical device software used for
diagnostic and triaging applications to drug candidate selection to
clinical trial design and interpretation. In this episode, FDA
regulatory attorneys Kellie Combs, Greg Levine, and Sarah
Blankstein explore the development and uptake of these technologies
in response to the ongoing COVID-19 pandemic, FDA s current
regulatory landscape for these technologies, recent steps FDA has
taken to update its regulatory approach to these tools in