Regulator Spotlight
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.
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ABOUT THE WEEKLY SUPPLEMENT
Along with a feature story on a presentation or panel discussion in which regulatory agency and pharmacopeia leaders address the challenges and developments in a key area of concern, our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting.
Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week.
Appended to the issue is a chronological listing of the headlines of the featured regulator stories since IPQ began its Weekly Supplement series in February 2024. Also appended are the headlines of the in-depth stories that IPQ has released since 2020. Those of especially high relevance to the regulator insights provided in this issue are indicated with a red star. Click on the headlines to access the stories.