Year-End Review & Look Ahead – FDA Watch
Wayne chats with the following guests in their respective fields of expertise:
- Pharma: Paul Kim, Principal, Kendall Square Policy Strategies LLC
- Devices: John Sawyer, President, Realistic Quality Solutions, LLC
- Food: Stuart Pape, Senior Partner and Food and Drug Chair, Polsinelli
- Cosmetics: Angela Diesch, Partner and Head of the Cosmetics Industry Group at PLG (Potomac Law)
Each guest dives into the top FDA developments from 2025 in their respective areas, as well as the top developments to watch for in 2026.
This episode and all bonus episodes do not include the usual Headlines and Resources Links segments.
About Our Guests
Paul Kim
Paul T. Kim, JD, MPP, is principal of Kendall Square Policy Strategies LLC, providing advice on FDA, life science, and public health policy to Fortune 500 companies, national patient advocates, life science trade associations, and emerging companies in the US, Europe and Korea.
Paul was head of the FDA and federal government strategies practices at a leading law firm for 20 years, following his work as counsel to the late Senator Edward Kennedy, Congressman Henry Waxman, and the late Senator David Pryor. Paul also worked for the FDA, the American Foundation for AIDS Research, and a global biopharmaceutical.
John Sawyer
John Sawyer is a medical device expert in quality management systems and regulatory affairs. His experience has focused on regulatory affairs, quality assurance, risk management, clinical affairs, and now cybersecurity. His current work has been establishing and improving quality systems and regulatory strategies for various modalities based on FDA’s QSR, ISO-13485, EU MDR, and CMDCAS.
He has spent time with firms both domestically and internationally for Class I, II, and III devices. He has his BA and MBA in Business Administration & Management.
Stuart Pape
Stuart Pape is a Senior Partner and Food and Drug Chair at Polsinelli. He consults clients on regulations imposed by the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), and similar health and safety regulatory bodies worldwide.
Stuart regularly appears before the FDA, USDA, Consumer Product Safety Commission, U.S. Customs and Border Protection, Federal Trade Commission, numerous other federal and state regulatory bodies, and the Congress of the United States. Stuart serves clients across the U.S. and around the world in many capacities. Previously, he served in various positions in the Office of the Chief of Counsel at the FDA, including as Associate Chief Counsel for food. He also served as executive assistant to FDA Commissioner Donald Kennedy.
Angela Diesch
Angela Diesch is a Partner with Potomac Law. There she leads the firm’s Cosmetics Industry practice group. She counsels companies in the cosmetics, over-the-counter drug, and medical device industries on all aspects of regulatory compliance, product development, labelling, and marketing. She is at the forefront of helping clients navigate the new Extended Producer Responsibility laws now in effect in various states’. She is particularly recognized for her expertise in the “natural” and “organic” sectors, helping clients responsibly launch innovative products that comply with FDA, FTC, and other federal and state regulations.
FDA Watch Podcast 