Following individual updates by compliance leaders from FDA’s centers for drugs, biologics, and veterinary medicine and the new cross-center inspection office at the closing day plenary session of the September, 2025 PDA Regulatory Conference, they participated together in a panel discussion that further explored some of the key operational and policy concerns impacting the agency’s evolving oversight model. Receiving attention were: ● the center/field reorganization ● artificial intelligence (AI) ● pre-approval inspections (PAIs) ● inspection site selection models ● unannounced foreign inspections ● xenotransplantation animals ● warning letter trends, and ● the rise in vet drug enforcement actions.
In the morning plenary session on the concluding day of the September 2025 PDA Regulatory Conference, CBER, CDER and CVM compliance office leaders and the acting director of the Office of Human and Animal Drug Inspectorate (OHADI) shed light on the current regulatory processes, priorities and enforcement outlook across their respective programs.
At the opening session of the 2025 PDA Regulatory Conference, a panel of senior FDA compliance leaders from CDER, CBER, CVM, and the Office of Inspections and Investigations (OII) explored the current inspection and compliance landscape – from the impact of FDA’s center/field reorganization to the evolving approaches for applying risk-based oversight and improving transparency and supply-chain quality.
At the opening plenary session of the September 2025 PDA Regulatory Conference, CBER Office of Compliance and Biologics Quality Consumer Safety Officer Jonathan Swoboda provided an update on CBER’s: ● compliance actions and product focus ● warning letter recipients and top cGMP citations during FY2025 ● recall activity, and ● center/field reorganization.
At the opening plenary session of the September 2025 PDA Regulatory Conference, FDA CDER Office of Manufacturing Quality [OMQ] Director Francis Godwin provided an update on GMP trends and recent enforcement activities. His presentation covered: ● an introduction to OMQ ● FY 2025 activities ● intravenous fluid shortages ● APIs for pharmacy compounding and related quality oversight, and ● a “chamber of horrors” case study.
At the regulatory session of the Summer 2025 CASSS CMC Strategy Forum on bioconjugates and multispecifics, a panel that included current and former regulators from different countries explored the characterization, potency assessment, and manufacturing challenges created by the design diversity and structural complexity of these products, and strategies for addressing the challenges and gaining agency clearance.
In a session on regulatory considerations at the Summer 2025 CASSS CMC Strategy Forum North America on bioconjugates and multispecifics, held in Gaithersburg, MD, in mid-July, regulators from Japan and Chile reviewed the experience of their respective agencies in this expanding product field and how approaches are evolving in the context of internal capabilities and international developments.
At the opening session of the Summer 2025 CASSS CMC Strategy Forum North America on novel bioconjugates and multispecifics, Health Canada Biologic and Radiopharmaceutical Drugs Directorate Senior Biologist/Evaluator Angela Yeung reviewed how the agency is addressing the regulatory challenges posed by novel antibody-based constructs. Her presentation covered: ● Health Canada’s review process for bioconjugates and multispecifics ● CMC considerations, and ● case studies from recent submissions.
At the June 2025 PDA Advanced Therapy Medicinal Product (ATMP) Conference held in Gothenburg, Sweden, EMA Pharmaceutical Quality Scientific Administrator Dolça Rogers discussed and shared case studies on: ● common CMC challenges for ATMPs and ● how the agency is engaging in international collaborations for more harmonized outcomes.
During the extended Q&A that concluded the regulatory session at the June 2025 CASSS CGTP Symposium, regulators from Italy, The Netherlands, Japan, Canada, and Spain shed further light on the issues and initiatives their respective agencies are engaged with at the national and international level to support cell and gene therapy development. Also participating in the Q&A was a former U.S. FDA CGT regulator.