Standards for Supplements

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.

The FDA approves asundexian, the first factor XIa inhibitor, cutting stroke risk 26% and setting a regulatory benchmark for factor XI drug developers.

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.

This week addressed AI accountability, CPHI award winners, NFC anticounterfeiting, first-in-class FDA approvals, and a shelved FDA voucher pilot lead this week’s roundup.

Cole and Jaenisch explain why defending against AI poisoning in pharma manufacturing calls for a data steward role, immutable instruction ledgers, and automation.

Regulators will test pharma companies against their own internal AI policies. Jaenisch, Muraru, and Pandey explain how to build defensible, inspection-ready AI practices.

FDA approved pimicotinib for TGCT based on a 56% response rate; its Project Orbis review signals tighter global launch planning for manufacturers.