Regulator Spotlight
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.
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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.