Regulator Spotlight
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.
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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.