Regulator Spotlight
At the 2025 IPEC-Americas Excipient World Conference, held in Maryland in mid-May, USP Senior Manager for Excipients Hong Wang reviewed USP’s evolving excipient strategies and recent standards initiatives. Her presentation covered: ● an introduction to excipients and the USP excipient strategy ● the excipient nomenclature guideline ● evolving/iterative approaches, and ● USP’s “Flexible Solution: Materials Program.”
[Editor’s note: Reflective of the pivotal role that pharmacopeial standards and guidance play in quality regulatory processes around the world, IPQ will now be featuring key presentations by pharmacopeial leaders at recent conferences – as well as those by regulators – in our Weekly Supplements.]
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ABOUT THE WEEKLY SUPPLEMENT
Along with a feature story on a presentation or panel discussion at a conference in which leading regulators 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.