The FDA has shelved its National Priority Voucher pilot, leaving sponsors that built CMC and launch-readiness plans around 1- to 2-month reviews facing uncertain timelines.
|Articles|July 29, 2010
Regulatory Roundup: European Medicines Agency Issues Drug Review Update; And More.
Author(s)Pharmaceutical Technology Editors
European Medicines Agency Issues Drug Review Update; And More
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The European Medicines Agency's Committee for Medical Products for Human Use issued an
The US Food and Drug Administration issued a
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The FDA approves asundexian, the first factor XIa inhibitor, cutting stroke risk 26% and setting a regulatory benchmark for factor XI drug developers.
Coverage from AAPS PharmSci 360 and CPHI Milan featured discussion about impurities, devices, and supply resilience. This week also included topics such as AI accountability, oral peptides, and new licensing deals.
No operator touches a CAR-T batch before demonstrating proficiency. Generative AI users should meet the same standard, and a higher one, because an AI error does not stay inside one batch.
The FDA grants accelerated approval to subcutaneous amivantamab for head and neck cancer, extending the IV-to-subcutaneous shift in biologics formulation.
USP data show fewer US drug shortages but longer ones, averaging 5+ years. Drug shortages are an incentive problem, not a manufacturing mystery.
The pharmaceutical supply chain is a complex system with high stakes. USP provides insights on how it is helping industry navigate global disruptions and procurement issues.
Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.
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