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// November 28, 2023
FDA's Draft Guidance for Topical Ophthalmic Drug Products: USP Standards ...
This year has seen a flurry of activity by the U.S. Food and Drug Administration surrounding ophthalmic products.
// November 27, 2023
Building a More Resilient Medicines Supply Chain
Building a More Resilient Medicines Supply Chain
In this Q&A with the Duke-Margolis Drug Supply Chain Resilience and Advanced Manufacturing Consortium, US Pharmacopeia (USP) policy expert Amy B. Cadwallader highlights the importance of multi-disciplinary, cross-functional coordination to strengthen the medicine supply chain and global public health resilience in the face of ongoing threats, like persistent drug shortages. This Q&A was first published in the Consortium's eNewsletter and is re-printed with the permission of the Duke-Margolis Center for Health Policy.
// November 27, 2023
Revisiting the Landscape of Potential Nitrosamines in Pharmaceuticals using CPCA fram...
USP’s Naiffer Romero has teamed up with researchers at LHASA Limited, AstraZeneca, Sai Life Sciences and Merck for collaborative research on nitrosamines impurities that was published this month in the Journal of Pharmaceutical Sciences. Quality Matters recently sat down with Romero, who leads USP’s Nitrosamines Exchange, to learn more about the new research and what it means for the field.
// October 24, 2023
Why cancer medicines are and continue to be vulnerable to drug shortages...
Analysis leveraging USP’s Medicine Supply Map suggests many of the essential cancer medicines have inherently vulnerable supply chains and are at greater risk for shortage compared to other generic medicines.
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