Enter your email below to subscribe to FDA Watch.
You’ll get an email as soon as new episodes are published.
Recent Episodes
-
How Industry Is Adapting to FDA’s Food Shifts
Wayne chats with Sarah Sorscher and Sarah Gallo about the current state of foods at FDA, concerns related to the agency’s budget, impacts of the government shutdown on the Human Foods program, how federal regulation might affect state regulation, changes to the GRAS process and post-market review, how industry is… Listen ⇢
-
Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs
In Part 3 of our series with Hyman, Phelps & McNamara, Wayne chats with Sara Koblitz, Kurt Karst, and Karin Hessler about hurdles facing generic drugs in today’s regulatory environment; pressure on industry to continue lowering drug prices; how Hatch-Waxman has played out over the past 40 years; how tariffs… Listen ⇢
-
Pharmaceutical Regulation, Compliance & Policy, Part 2: Navigating the New Enforcement Environment
In Part 2 of our series with Hyman, Phelps & McNamara, Wayne chats with John Claud, Peter Dickos, and Andrew Hull about the current enforcement environment at FDA; foreign inspections of pharmaceuticals and how companies should respond to 483s; False Claims Act theories for liability; key considerations for consent decrees… Listen ⇢
-
Examining CDRH, Device Innovation & Agency Communication
Wayne chats with Sandra Cohen Kalter and Steve Silverman about whether CDRH has the resources and cross-agency collaboration it needs to fulfill its regulatory mandate, FDA’s capacity to support innovation amid review pressure and staffing cuts, how companies can find reliable up-to-date regulatory information, FDA’s ability to monitor safety and… Listen ⇢
-
A Look at FDA’s Drug Review Reset
Wayne chats with Dr. Cartier Esham and Elizabeth Jungman about FDA’s maintenance of its drug review process amid staffing cuts; the agency’s new PreCheck program and how it may proceed; FDA’s evolving stance on confirmatory evidence and accelerated approvals; agency budgets; AI use at the agency and in industry; and… Listen ⇢
-
Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases
In Part 1 of our series in collaboration with Hyman, Phelps & McNamara, P.C., Wayne chats with James Valentine, Frank Sasinowski, Louise Himmelstrup, and Kate McCurdy about the current status of orphan drug approvals at FDA; confirmatory evidence in rare disease development programs, how sponsors and FDA are engaging with… Listen ⇢
-
Unpacking OMUFA
Wayne chats with Meredith Petillo about the recent FDA warning letters to sunscreen brands; “foodification” risks in beauty and personal care products; how companies can prepare for potentially increased agency focus on non-traditional product formats; OMUFA and how it could impact innovation in the OTC space; and much more. Listen ⇢
-
FDA’s Fight Against Ultraprocessed Foods
Wayne chats with Claudia Lewis and Ricardo Carvajal about FDA’s focus on ultraprocessed foods; GRAS regulation and former FDA Commissioner Kessler’s citizen petition; potential agency updates to food nutrition labeling; inspections and food safety; FDA’s use of AI in food decision-making; and much more. Listen ⇢
-
Dissecting the Direction of CDER and CBER with Paul Kim
Wayne chats with Paul Kim about major legal concerns with what FDA is aiming to accomplish; priorities for CDER Director Dr. George Tidmarsh and CBER Director Dr. Vinay Prasad; the direction of CDER and CBER on orphan drugs, rare diseases, and vaccines; reviews under the Commissioner’s National Priority Voucher Program;… Listen ⇢
FDA Watch Podcast 