Enter your email below to subscribe to FDA Watch.
You’ll get an email as soon as new episodes are published.
Recent Episodes
-
Examining the Cosmetics Compliance and Enforcement Landscape
Shelly and Wayne chat with Justin Prochnow, Partner in the Denver office of Greenberg Traurig, about what FDA could be prioritizing in cosmetics under new FDA Commissioner Dr. Marty Makary; compliance and enforcement obstacles with MoCRA implementation; challenges companies are facing from class-action attorneys; the intersection of cosmetics and environmental… Listen ⇢
-
A New Era of Unprecedented Change
Shelly and Wayne chat with Nancy Myers, CEO of Catalyst Healthcare Consulting, and Stuart Pape, Senior Partner and Chair of the FDA Practice at Polsinelli, about what companies should be doing now amid changes at FDA, including the recent confirmation of Dr. Marty Makary as the agency’s new commissioner; the… Listen ⇢
-
The Latest in FDA’s Focus on Foods
Shelly and Wayne chat with Dr. Susan Mayne and Dr. Peter Lurie about why it took FDA so long to ban Red Dye No. 3, the agency’s “healthy” claim final rule, where FDA stands with reducing sodium in human foods, the push to eliminate the self-affirmed GRAS pathway, and much… Listen ⇢
-
What’s Happening in Software and Device Regulation
Shelly and Wayne chat with Jennifer Newberger and Michael Gaba about anticipated changes in the review and approval of PMAs, 510ks, and de novo applications; clinical trial requirements for SaMD; and much more. Listen ⇢
-
The Evolution of Clinical Trials
Shelly and Wayne chat with Steve Grossman and Anthony Brogno about how drug development, drug approvals, and clinical trials could be evolving under the new administration’s FDA; priorities in clinical trails for the new FDA Commissioner; and the intersection of budget and the FDA’s use of AI in its review… Listen ⇢
-
Navigating FDA’s Future: Janet Woodcock on the Evolving Regulatory Landscape
Shelly and Wayne chat with Janet Woodcock, M.D., former FDA Principal Deputy Commissioner on the agency’s approach to navigating the current regulatory environment; the increasing role of AI in FDA decision-making; the future of the agency’s staffing, resources, and regulatory frameworks; and much more. Listen ⇢
-
A Deep Dive Into MoCRA
Shelly and Wayne chat with Will Woodlee and David Lennarz about the top priorities in cosmetics regulation for the next FDA Commissioner and their insights on all things MoCRA. Listen ⇢
-
Food Regulation and Safety Under the New Administration
In this episode, Shelly and Wayne chat with Stuart Pape and Domenic Veneziano on the top priorities in food regulation for the next FDA Commissioner, increased FSVP inspections, key issues surrounding food importation, the Human Foods program, and more. Listen ⇢
-
The New-Look FDA: What’s on the Horizon?
Shelly and Wayne chat with Marc J. Scheineson and Steven A. Grossman about what to expect from FDA under the new administration, including the transition process, Robert F. Kennedy Jr.’s role, staffing issues, funding, and more. Listen ⇢
FDA Watch Podcast 