Devices, Disruption & the Road Ahead

Shelly and Wayne chat with Dr. Daniel Schultz, Principal of Medical Devices and Combination Products at Eliquent, and Jonathan Kahan, a Global Regulatory Partner at Hogan Lovells. You'll hear their thoughts on the effect of CDRH staff reductions on medical device reviews and market authorizations; the outlook for device regulation in the next few years; how FDA is responding to device shortages and supply interruptions; the effectiveness of the current post-market surveillance system in detecting device-related adverse events; the possible effect of eliminating the Freedom of Information staff on the agency's ability to be responsive and transparent to the public; and much more. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: Drug development is decelerating amid FDA's staffing cuts Devices: A federal court shuts down an FDA rule that reclassifies laboratory services as medical devices Food: FDA did not disclose information surrounding fatal E. coli outbreak linked to lettuce Cosmetics: PCPC releases statement following FDA's announcement to phase out animal testing requirements for monoclonal antibodies and other drugs 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 [email protected].  Music by Dvir Silver from Pixabay.