Regulator Spotlight
At the 2025 IPEC-Americas Excipient World Conference, held in Maryland in mid-May, USP Senior Director for Global Science and Standards in Foods and Excipients Catherine Sheehan reviewed USP’s emerging/evolving approaches for addressing: ● excipient quality challenges ● phospholipid standards and solutions for complex injectables, and ● novel excipients and CGTs. In talks the next day, Sampada Kharade spotlighted USP’s engagement with the challenges of LG polymers, and Katie McGowan focused on USP’s Donations Program and how it supports excipients not yet covered by compendial standards.
[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 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.