FDA Watch

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.

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.

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.

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.

In this second part of our series in collaboration with White & Case and BRG, Wayne chats with Bethany Hills, Partner at White & Case, and Dan Troy, Managing Director at BRG. Together, they discuss where pricing pressures show up at FDA; how pricing issues affect how companies should think about evidence packages, differentiation claims, and life-cycle expansion; product features that often become flashpoints in pricing issues with FDA; lawful product differentiation versus differentiation that may later be portrayed as regulatory gaming; why CMC issues, manufacturing resilience, and shortage risk become more consequential amid pricing pressure; documentation surrounding regulatory and product-presentation decisions that could be second-guessed through a pricing lens; 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.