FDA Watch

In this second part of our new series in collaboration with Analysis Group, Wayne chats with Dr. Mary Beth Ritchey, Principal of Med Tech Epi LLC, and Associate Research Professor at Rutgers University; and Cori Maegley, Vice President of Partnerships Management at the National Evaluation System for health Technology (NEST), a Medical Device Innovation Consortium initiative. Together, they discuss how real-world evidence (RWE) applies to medical devices; where RWE for medical devices comes from; what CDRH can learn from CDER and CBER about using RWE and vice versa; examples of real-world application of real-world evidence in devices; how FDA's approach to RWE compares to other countries; how companies determine how much they rely on RWE and how CDRH is collaborating to help companies make those decisions; what makes RWE reliable enough for regulatory use and the importance of data quality; how AI plays into RWE for devices; 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.

Wayne chats with Brian Malkin, Partner at Spencer Fane. You'll hear Brian's thoughts on potential FDA leadership under Heidi Overton, early priorities for drug and biologics companies, implications for drug pricing, AI in drug development, new approach methodologies and the shift away from animal testing, sponsor use of NAMs in place of traditional animal studies, skinny labeling, and implications for generic drugmakers, overlooked and emerging FDA issues for pharma and biotech companies, and much more.
In our headlines segment, Wayne highlights these major developments: 

FDA announces broad recruitment effort to expand range of people on advisory committees 

Pharma: FDA launches expedited Investigational New Drug (IND) pilot program 

Devices: AI and robotic surgery among FDA's top areas of focus in FY27 guidance priorities 

Food: PepsiCo recalls over 122,000 cases of Gatorade after bottles were found to contain undisclosed Yellow No. 5 and/or Yellow No. 6 

Cosmetics: FDA informs cosmetic product facilities and retailers that the agency does not provide certificates to verify compliance for cosmetic product facility registration
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 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.

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.