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|October 2, 2001
- Pharmaceutical Technology-10-02-2001
- Volume 25
- Issue 10
Safety and Manufacturing Standards
Author(s)Jill Wechsler
FDA may adopt new requirements to enhance the safe use of pharmaceuticals and ensure that all US drugs are available when needed.
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Outsourcing Outlookabout 25 years ago
Hydrogels for the Controlled Release of Pharmaceutical Proteinsabout 25 years ago
Near-Infrared Inspection Complements Other QC Systemsabout 25 years ago
Current Status of the Oral Delivery of Insulinabout 25 years ago
Laboratory Equipment Qualificationabout 25 years ago
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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.
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