FDA Watch

Wayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association, and Claire Bing, CEO and Founder of Confiance Cosmetic Group. You'll hear their thoughts on recent activity in the cosmetics space; FDA's PFAS report and the January 1 state compliance deadline; the agency's guidance on inspections and other areas; the impact of rising state actions; how the agency can battle misconceptions about the cosmetics industry and product safety; how FDA can support industry; what happened with a recent Washington state interim policy on lead; the need for clarity on fragrance allergen labeling, cosmetic GMPs, and formaldehyde releasers; and much more.
In our headlines segment, Wayne highlights these major developments: 

FDA makes several official appointments
Pharma: U.K. commission issues recommendations for regulating AI in medicine
Devices: CDRH launches Rare Disease Impact Initiative
Food: Cyclospora outbreak draws attention to sharp decline in FDA oversight of imported foods
Cosmetics: From Cosmetics Business, FDA's peptide review could have significant implications for brands using peptides

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.

Wayne chats with Mason Weeda, Managing Principal at OFW Law and Chair of the firm's FDA Food Practice, and Jessica O'Connell, Partner at Covington and Co-Chair of the firm's Food, Drug, and Device Practice Group. You'll hear their thoughts on FDA's handling of the ongoing Cyclospora outbreak, other food enforcement actions and inspections, potential changes ahead to the GRAS framework, where the agency's fight against synthetic food dyes stands, top-of-mind issues for the rest of 2026 and 2027, and much more.
In our headlines segment, Wayne highlights these major developments: 

White House nominates Dr. Heidi Overton to be next FDA Commissioner 

HHS plans to create two new FDA deputy commissioner positions in technology and drug areas 

Pharma: FDA published 55 new and revised product-specific guidances surrounding generic drugs 

Devices: FDA authorizes first wearable device in U.S. that continuously monitors glucose and ketone levels 

Food: Cyclospora outbreak spreads to 20 states 

Cosmetics: PCPC urges U.S. and Canadian officials to resolve escalating trade tensions
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.

In this third part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-chair of the Life Sciences industry team at AGG; and Laura LaBrie, Associate in the Healthcare and Food & Drug practices at AGG. Together, they discuss recent actions by FDA's Office of Prescription Drug Promotion surrounding direct-to-consumer advertising, AI's role with OPDP enforcement and company promotion and review, and promotional areas getting the most attention in review committees recently. They also address how to navigate issues with competitor promotion, areas in advertising and promotion that could be in focus in 2027, 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 info@fdawatch.net. 

Music by Dvir Silver from Pixabay.

Wayne chats with Cathy Burgess, Partner and Head of the FDA Compliance and Enforcement Team and FDA Practice at Alston & Bird, and Michael Gaba, Food and Drug Vice Chair at Polsinelli. You'll hear their thoughts on what's happening these days at CDRH; key issues for medical device manufacturers, such as QSMR implementation and enhanced cybersecurity requirements; the evolution of digital health and its impact on clinical decision support technologies and wellness products; what could be next for user fee authorization; potential risks with AI in medical devices; and much more. 
In our headlines segment, Wayne highlights these major developments: 
Pharma: Advisory panel votes to recommend allowing compounding pharmacies to prepare six peptides 

Devices: FDA selects Dexcom as first participant in TEMPO pilot 

Food: FDA issues final order revoking the authorization for two food dyes 

Cosmetics: Survey notes nearly 73% of daily cosmetic users believe FDA tests cosmetics for safety
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.

Wayne chats with Daniel Kracov, Partner and Chair of the Life Sciences Industry Group at Arnold & Porter, and Dr. Gayatri Rao, Director at Hyman, Phelps & McNamara. You'll hear their thoughts on Operation TrialBlazer; what's been happening lately with CBER and CDER; the latest in rare diseases and orphan drugs; developments in cell and gene therapy; the Plausible Mechanism Framework; the situation with China and global drug development; and much more. 

In our headlines segment, Wayne highlights these major developments: 
Acting FDA Commissioner Kyle Diamantas releases new strategic framework built around four public health priorities 

Pharma: FDA makes 14 CRLs available, rejecting drug applications, despite previously pausing real-time CRL transparency initiative
Devices: FDA clears Software as a Medical Device with patient-facing LLM
Food: FDA delays publication of proposed rule to eliminate the GRAS pathway 
Cosmetics: PCPC urges U.S. Trade Representative to ensure cosmetics and personal care products are prioritized in proposed U.S.-China Board of Trade

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.