FDA Watch

Wayne chats with Rumi Young, Director of Regulatory Policy at Novo Nordisk, and Jamie Gamerman, Head of Regulatory Policy at UCB. You'll hear their thoughts on how FDA policy is developed and is evolving; how previous PDUFAs have changed the agency's policy agenda and how those commitments translate into guidance development; the most important scientific or technical inflection points driving FDA policy right now; what drives the development of new agency frameworks or programs; how companies internalize new FDA policies where disconnects may exist; FDA's efforts to balance scientific integrity with regulatory flexibility in policy development for issues such as rare diseases; and much more.
In our headlines segment, Wayne highlights these major developments: 
Pharma: FDA awards two more vouchers under Commissioner's National Priority Voucher pilot program
Pharma and Devices: FDA updates approach to incorporating RWE into drug and medical device application reviews
Food: Consumer advocate coalition urges top health officials to take action to protect infant formula safety amid ongoing Clostridium botulinum outbreak
Cosmetics: FDA finds data insufficient to determine safety of most PFAS in cosmetics
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 the following guests in their respective fields of expertise:
Pharma: Paul Kim, Principal, Kendall Square Policy Strategies LLC
Devices: John Sawyer, President, Realistic Quality Solutions, LLC
Food: Stuart Pape, Senior Partner and Food and Drug Chair, Polsinelli
Cosmetics: Angela Diesch, Partner and Head of the Cosmetics Industry Group at PLG (Potomac Law)
Each guest dives into the top FDA developments from 2025 in their respective areas, as well as the top developments to watch for in 2026.
This episode and all bonus episodes do not include the usual Headlines and Resources Links segments.
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 Dr. Ritu Nalubola, Director of Life Sciences and Healthtech at Marwood Group and former FDA leader, spanning several roles over more than two decades. Together, they discuss how deregulation has been playing out at FDA; industry incentive programs, such as the Commissioner's National Priority Voucher program and PreCheck program; how agency efforts to streamline regulation could affect product safety; how tariffs and MFN impact FDA and industry; the agency's role in regulating AI and supporting AI applications; broader initiatives on health data and governance; Ritu's thoughts on where things may be headed in 2026; 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.

In this fourth and final part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Michelle Butler, Director at HPM; Charles Raver, Associate at HPM; and Josephine Torrente, Director at HPM. Together, they discuss potential avenues to resolve a disagreement informally; how the formal dispute resolution (FDR) process works; why companies would engage in the FDR process and what constitutes a win; common misconceptions about the FDR process; what changes may be coming to the FDR process; 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 Rachel Raphael, Partner at Morgan Lewis, and Ronie Schmelz,  Partner at K&L Gates. You'll hear their thoughts on what's happening at FDA in cosmetics and personal care products; how companies should navigate ingredient concerns amid federal inaction, aggressive state laws, and stricter foreign regimes; the state of regulation surrounding labeling and advertising and promotion; what industry should be keeping an eye on heading into 2026; and much more.
In our headlines segment, Wayne delves into these major developments:
Tensions reported between FDA Commissioner Dr. Marty Makary and HHS Secretary Robert F. Kennedy Jr.
Pharma: From the Guardian, finding CDER Director replacement left FDA in state of "turmoil" and "tensions"
Devices: From the Economic Times, European medical device manufacturers feeling U.S. tariff squeeze
Food: RFK Jr. calls for greater food allergy research at Food Allergy Fund Leadership Forum
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.