In this first part of our series in collaboration with Hyman, Phelps & McNamara, P.C. (HPM), Wayne chats with James Valentine, Director at HPM; Frank Sasinowski, Director at HPM; Louise Himmelstrup, Vice President of Regulatory Affairs at Zevra Therapeutics; and Kate McCurdy, Co-Founder and Board Chair of the Barth Syndrome Foundation. Together, they discuss the current status of orphan drug approvals at FDA; why confirmatory evidence is particularly important in rare disease development programs, how confirmatory evidence is being and has been applied, and how confirmatory evidence is evolving; new ways in which sponsors and FDA are engaging with accelerated approvals through greater use of intermediate clinical endpoints; ultra-rare disease pathways, including FDA's new Rare Disease Evidence Principles, and why diseases like Barth syndrome and Niemann-Pick disease type C face such challenges with the agency; and much more.

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.

Wayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association. You'll hear her thoughts on recent FDA warning letters to sunscreen brands; the mention of sunscreens in the new MAHA report; "foodification" risks in beauty and the personal care products space; how companies can prepare for potentially increased agency focus on non-traditional product formats; OMUFA, how it could impact innovation and competition in the OTC space, and its effect on small businesses; and much more.

Check out IBA's Cosmetics Convergence Fall 2025: Indie Beauty Compliance Edition, a two-day virtual conference happening Nov. 12–13, for further updates and practical guidance on beauty and personal care industry compliance. FDA Watch listeners get 10% off registration with discount code IBAFDA10.

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

HHS issues new MAHA report

President Trump signs executive order regarding DTC advertising; FDA Commissioner Makary sends letters to pharma companies saying new rules and stricter enforcement coming

Pharma and Devices: OMB releases Spring 2025 regulatory agenda

Food: FDA launches new Nationalized Entry Review program

Cosmetics: EU bans gel nail polishes that continue to be sold in U.S.

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 Claudia Lewis, Co-Chair of the FDA Group at Venable, and Ricardo Carvajal, Director at Hyman, Phelps & McNamara. You'll hear their thoughts on FDA's focus and direction on ultraprocessed foods; GRAS regulation and former FDA Commissioner Dr. David Kessler's citizen petition; potential agency updates to food nutrition labeling; inspections and food safety; FDA's use of AI in food decision-making; and much more.

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

Pharma: Substantial publicity surrounds firing of CDC Director Susan Monarez

Devices: FDA launces Regulatory Accelerator for digital health devices

Food: HHS and Secretary Kennedy to issue second MAHA report

Cosmetics: FDA issues warning letters to sunscreen companies making mousse products

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 Paul Kim, Principal of Kendall Square Policy Strategies and former head of FDA and federal government strategies practices at a leading law firm for 20 years. Together, they discuss major legal issues and concerns with what the agency is aiming to accomplish; priorities for CDER Director Dr. George Tidmarsh and CBER Director Dr. Vinay Prasad; the direction of CDER and CBER on orphan drugs, rare diseases, and vaccines; reviews under the Commissioner's National Priority Voucher Program; 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.

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.