In this second part of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with Howard Sklamberg, Partner at Arnold & Porter; Eva Temkin, Partner at Arnold & Porter; and Marko Topalovic, Chief AI Officer at Clario, which recently acquired ArtiQ, where he was Founder and CEO. Together, they discuss how AI can accelerate drug discovery and design; how AI could be used in the clinical trial process; how FDA could use AI to evaluate medical product manufacturers’ data integrity operations and in inspections; how AI could play a part in product applications; and much more.

Access Arnold & Porter’s recent AI survey here.

This episode and the rest of our series do not include the usual Headlines and Resources Links segments.

To 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.

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 info@fdawatch.net.

Music by Dvir Silver from Pixabay.

Shelly and Wayne chat with Dr. Michelle McMurry-Heath, Founder and CEO of BioTechquity Clinical, and Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-Chair of the Life Sciences industry team at Arnall Golden Gregory LLP. You’ll hear their thoughts on the potential effects that FDA staffing cuts may have on drug and biologics approvals; how the current environment may affect investments in drug and biotech development; what companies can do to amid agency staffing shortages; how FDA can aim to include all demographics of patients in trials; and much more.

In our headlines segment, Shelly and Wayne delve into these major developments:

Pharma: Trump administration makes exception for pharmaceuticals amid rollout of tariffs

Devices: Industry continues to face the consequences of cutbacks at CDRH

Food: Food company completes FDA pre-market consultation for human food made with cultured pork fat cells

Cosmetics: PCPC executive issues statement on impact of Trump administration’s reciprocal tariffs on cosmetics and personal care products industry

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.