FDA Watch

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 [email protected].

Music by Dvir Silver from Pixabay.

Wayne chats with Deb Autor, CEO of Healthcare Innovation Catalysts, and Paul Offit, M.D., Director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at the Children's Hospital of Philadelphia. You'll hear their thoughts on vaccine development, policy, testing, and funding, including COVID vaccines; the new Commissioner's National Priority Voucher Program; the Sarepta gene therapy episode; leadership transitions at CDER and CBER; AI in pharmaceutical regulation; and much more.

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

Pharma: Vinay Prasad back as CBER head after ousting

Devices: Troubles continue with FDA's new AI tool, Elsa

Food: FDA and USDA publish joint RFI to help define ultra-processed foods

Cosmetics: Anxiety over U.S.-imposed tariffs sparks shopper panic in late July

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.

Wayne chats with John Taylor, Head of the Quality and Compliance Practice at ELIQUENT and 30-year FDA, industry, trade association, and consulting veteran. Together, they discuss Taylor's pedigree; his perspective on the most pressing issues FDA is facing in drugs, devices, foods, and cosmetics; the agency's increasing use of AI; what FDA's top priorities should be moving forward; and much more.

This episode and all bonus episodes 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 [email protected].

Music by Dvir Silver from Pixabay.

Shelly and Wayne chat with the following guests in their respective fields of expertise:

• Pharma: Naomi Lowy, M.D., Principal Drug Regulatory Expert, Hyman, Phelps & McNamara
• Devices: Claire Davies, Shareholder at Polsinelli
• Cosmetics: Angela Diesch, Partner and Head of the Cosmetics Industry Practice at Amin Wasserman Gurnani
• Food: Frank Yiannas, former FDA Deputy Commissioner of Food Policy & Response at FDA

Each guest dives into their top three FDA developments from the first half of 2025 in their respective areas.

This episode and all bonus episodes 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 [email protected].

Music by Dvir Silver from Pixabay.

Shelly and Wayne chat with Emily Manoso, Executive Vice President, Legal & Regulatory Affairs, and General Counsel at the Personal Care Products Council. You'll hear her thoughts on the state of cosmetics regulation and safety under the new administration, cosmetic and personal care product imports, the implementation and enforcement of MoCRA, FDA's fragrance allergen labeling rule, and much more.

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

HHS and FDA launch public request for information to identify and eliminate outdated or unnecessary regulations

Pharma: FDA shifts position on COVID-19 vaccines

Devices: FDA approves first at-home cervical cancer testing kit

Food: FDA launches "more robust, transparent" post-market chemical review program for food

Cosmetics: FDA issues warning on contaminated tattoo inks

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.

In this third and final part of our AI series in collaboration with Arnold & Porter, Shelly and Wayne chat with Philip Desjardins, Partner at Arnold & Porter; Mahnu Davar, Partner at Arnold & Porter; and Dr. William Maisel, Vice President and Senior Medical Officer at Intuitive, and former Director of the Office of Product Evaluation and Quality at the Center for Devices and Radiological Health at FDA. Together, they discuss the use of AI for clinical decision support, in regulation and pharmacovigilance functions, and in diagnostic and monitoring tools; AI's impact on advertising and promotion; what "AI washing" is and why it's important to distinguish real AI innovation from marketing hype; FDA's first AI-assisted scientific review pilot; 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 [email protected].

Music by Dvir Silver from Pixabay.

Shelly and Wayne chat with Martin Hahn, Global Regulatory Partner at Hogan Lovells, and Tony Pavel, Partner at Keller and Heckman. You'll hear their thoughts on global food supply chain vulnerabilities and how FDA is monitoring them; how U.S. tariffs on imported food products influence the availability and safety oversight of essential goods like formula or medical nutrition; how FDA is working with international partners to improve coordination and transparency; FDA measures to ensure a more resilient and responsive infant formula supply; and much more.

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

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

President Trump signs an executive order that aims to reduce drug costs by basing payments for certain medicines on their prices in other countries

Pharma: FDA Commissioner Dr. Marty Makary says layoffs won't hinder the agency's target dates for drug reviews

Devices: Two U.S. Senators introduce legislation encouraging the use of AI-enabled medical devices

Food: HHS, FDA announce plans to phase out synthetic dyes in nation's food supply

Cosmetics: ICCS shares case studies and mock dossiers as examples of how new approach methodologies can be utilized

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.

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 [email protected].

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 [email protected].

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 [email protected].

Music by Dvir Silver from Pixabay.