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The Rise of Real-World Evidence in Regulatory Strategy, Part 1: RWE in Rare Disease Drug Development Sep 21, 2026

Show notes

In this first part of our new series in collaboration with Analysis Group, Wayne chats with Dr. James Signorovitch, Managing Principal at Analysis Group; Bethany Hills, Regulatory Partner at White & Case; and Dr. Dilesh Doshi, Vice President of Global Health Economics & Outcomes Research at Acadia Pharmaceuticals. Together, they discuss FDA's ongoing commitment to rare disease drug development; defining real-world evidence (RWE) in the context of FDA and rare diseases; building representative and trustworthy patient registries; examples of RWE and registries supporting rare disease research and regulatory decision-making; making RWE a more systematic part of drug development and FDA evaluation; clinical development program reliance on RWE to support regulatory applications; the role of AI in collecting, analyzing, and applying RWE in rare disease drug development; and much more.

This episode and the rest of our series do not include the usual Headlines segment.

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.

What's Actually Happening in Cosmetics & Personal Care Sep 14, 2026

Show notes

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.

Food Safety in the Spotlight Sep 08, 2026

Show notes

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.

FDA Legal, Regulatory & Compliance Issues, Part 3: Advertising & Promotion Aug 17, 2026

Show notes

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.

Keeping Up with Medical Device Manufacturing and Digital Health Aug 10, 2026

Show notes

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.

An Extensive Breakdown of the Pharmaceutical and Biologics Landscape Aug 03, 2026

Show notes

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.

FDA Legal, Regulatory & Compliance Issues, Part 2: Customs Regulation & International Trade Jul 27, 2026

Show notes

In this second part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Luis Arandia Jr., Partner and Co-chair of International Trade at AGG, and Allison Raley, Partner in AGG's Corporate & Finance practice and Chair of the firm's International Compliance & Risk team. Together, they discuss how pharmaceutical and biologics companies should rethink global supply chains in light of the Section 232 tariffs affecting patented pharmaceutical products; common customs and trade compliance issues with imported FDA-regulated goods; legal risk-mapping to avoid detentions, refusals, and unexpected duty exposure; potential tariff actions impacting medical devices; how shifting U.S. trade policies are changing global supply chains for pharmaceuticals, biologics, and medical devices; the impact of heightened enforcement on forced labor in global supply chains; how industry should manage sanctions and export control exposure; 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.

FDA Legal, Regulatory & Compliance Issues, Part 1: FDA & DOJ Enforcement Jul 20, 2026

Show notes

In this first part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Gabriel Scannapieco, Partner at AGG and Co-chair of the firm's Life Sciences industry team. Together, they discuss trends in FDA and DOJ enforcement in 2026; how FDA and DOJ have approached the oversight of GLP-1 drugs; DOJ's non-prosecution agreement resolutions with Alibaba and AUS Merchant Services and what they mean for FDA enforcement; other products drawing attention from FDA and DOJ; recent FDA enforcement actions; what companies should do now and what should they watch for in the second half of the year related to enforcement; 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.

Midyear Review: 2026 So Far & a Look Forward Jul 13, 2026

Show notes

Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies LLC, and Dr. Susan Mayne, Adjunct Professor at the Yale School of Public Health and former Director of FDA's Center for Food Safety and Applied Nutrition. Together, they dive into the top FDA developments from the first half of 2026 in several areas, as well as the top developments to watch for in the second half of the year.

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 info@fdawatch.net.

Music by Dvir Silver from Pixabay.

From Price Strategy to Enforcement Risk Jul 06, 2026

Show notes

In this third and final part of our series in collaboration with White & Case and BRG, Wayne chats with Lauren Papenhausen, Partner at White & Case's Boston office, and Edward Buthusiem, Managing Director at BRG. Together, they discuss pricing-related government enforcement risks and the legal framework; commercialization strategies under heightened enforcement scrutiny; internal investigations and distinguishing isolated issues from systemic compliance failures; board and audit committee oversight of pricing compliance and internal controls; emerging enforcement risks from state-level drug pricing regulation; 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.

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