FDA Watch

In this second part of our series in collaboration with Covington, Wayne chats with Sarah Cowlishaw, Partner in Covington's European Food, Drug and Device Practice; John Balzano, Partner in Covington's China Food, Drug and Device Practice; and Julia Post, Of Counsel in Covington's U.S. and China Food, Drug and Device Practices. Together, they discuss the top issues in the global device landscape; developments in the European and Chinese medical device spaces; cross-border access to and transfers of U.S. and Chinese data and biospecimens; how Europe and China are approaching digital health and AI in device regulation; what device companies doing business in the U.S., European Union and China should be watching for over the next year; 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 David Lennarz, President of Registrar Corp., 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. You'll hear their thoughts on the Human Foods Program's 2026 priority deliverables; how the new food pyramid/dietary guidelines may impact food and nutrition policy; the state of FDA's focus on food dyes; the latest labeling and ingredient disclosure; the direction of infant formula following recent recalls; GRAS reform and general food safety oversight; and much more.
In our headlines segment, Wayne highlights these major developments:
FDA reports efficiencies with ImportShield Program
Pharma: FDA and EMA jointly issue 10 guiding principles on AI in drug and biologics development
Devices: FDA increases scrutiny of direct-to-consumer self-collection kits by treating certain collection devices as regulated medical devices
Food: FDA's Human Foods Program released 2026 priority deliverables
Cosmetics: Cosmetics products potentially exposed to rodents and rodent activity at Minnesota distribution facility 
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.

In this first part of our series in collaboration with Covington, Wayne chats with Amy Leiser, Special Counsel at Covington; Scott Danzis, Partner at Covington; and Susan Van Meter, President of the American Clinical Laboratory Association (ACLA). Together, they discuss the history of laboratory developed test (LDT) regulation; ACLA engagement with FDA and Congress on potential diagnostics reform legislation; FDA's subsequent LDT regulation and ACLA's  decision to initiate litigation; current issues facing laboratories and in vitro diagnostics manufacturers; how the rise of AI is impacting diagnostics; the potential for Congress to reengage on diagnostics regulation moving forward; 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 Mike Ryan, Executive Vice President at ELIQUENT and former FDA staffer at CDRH, and Michael Gaba, Food and Drug Vice Chair at Polsinelli. You'll hear their thoughts on where the relationship between FDA and the device industry stands right now; factors that influence how reviewers assess risk, credibility, and readiness during submission reviews; the role of the TPLC approach at CDRH; FDA's elimination of the requirement that RWE submissions include identifiable patient-level information; practical changes sponsors can make to improve regulatory outcomes, without increasing time or cost; and much more.
In our headlines segment, Wayne highlights these major developments: 
Pharma: FDA outlines new "more flexible" approach to CMC requirements for cell and gene therapies
Devices: FDA publishes two final guidance documents clarifying wearable and AI-enabled device oversight
Food: FDA Commissioner Makary chats about new food pyramid on NPR's All Things Considered
Cosmetics: U.S. Rep. Randy Weber introduces PACK Act
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 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.