Wayne chats with Neil O’Flaherty, Partner and Head of the Medical Device Practice Group at Amin Wasserman Gurnani, and Bobbi Druyor-Sanchez, Partner with NDA Partners. You’ll hear their thoughts on what’s happening at CDRH with warning letters and inspections for medical devices, AI-enabled medical devices and the ongoing situation with Whoop, and much more.

In our headlines segment, Wayne delves into these major developments:

FDA releases new staff manual on “Gold Standard Science” policy
Pharma: U.S. District Court upholds FDA authority to regulate homeopathic drugs as “new drugs” under the FD&C Act
Pharma: HHS brings back task force on childhood vaccines
Devices: FDA declares PFAS in medical devices safe
Food: FDA issues warning about imported cookware that may leach lead into food
Cosmetics: In recent webinar, experts outline growing complexity of biodiversity compliance for cosmetics and personal care companies

In our Resource Links segment, we list key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net.

Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.

Music by Dvir Silver from Pixabay.