The Top 3 Developments of 2025 in Pharma, Devices, Cosmetics & Food – FDA Watch
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.
About Our Guests
Naomi Lowy
Naomi Lowy, M.D., brings leadership experience from the FDA’s Center for Drug Evaluation and Research, where she most recently served as Deputy Director of the Division of General Endocrinology. During her 18-year tenure, she championed regulatory science and policy, acting as division signatory on new molecular entities for rare endocrine disorders and managing complex 505(b)(2) applications. Now a Principal Drug Regulatory Expert at Hyman, Phelps & McNamara in Washington, DC, she offers clients strategic and comprehensive guidance across the full spectrum of drug development.
Claire Davies
Claire Davies is a Shareholder at Polsinelli, where she counsels clients on FDA regulatory issues affecting medical products. Before joining Polsinelli, Claire spent nearly a decade in FDA’s Office of the Chief Counsel, advising agency officials on, among other things, emergency use authorizations, user fee negotiations, and programs to expedite access to innovative products.
Angela Diesch
Angela Diesch heads Amin Wasserman Gurnani’s Cosmetics Industry practice. Angela assists companies in complying with regulatory requirements applicable to the manufacture, marketing, and distribution of cosmetics, foods, dietary supplements, OTC drugs (including homeopathic), and medical devices. With a unique focus on the “natural” and “organic” sectors of consumer products, she advises clients at all stages of product development, including determining correct product classification and whether premarket notifications are needed.
Frank Yiannas
Frank Yiannas is a renowned food safety leader and executive, food system futurist, author, professor, past president of the International Association of Food Protection, and advocate for consumers. Most recently, he served under two different administrations as the Deputy Commissioner for Food Policy and Response at FDA, a position he held from 2018 to 2023, after spending 30 years in leadership roles with two industry giants: Walmart and the Walt Disney Company.
FDA Watch Podcast 