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.
News|Articles|October 2, 2004
- Pharmaceutical Technology-10-02-2004
- Volume 28
- Issue 10
October 2004
Author(s)Pharmaceutical Technology Editors
Pharmaceutical Science & Technology News
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Articles in this issue
about 22 years ago
A Novel Freeze Pelletization Technique for Preparing Matix Pelletsabout 22 years ago
Aseptic Processing: A Review of Current Industry Practiceabout 22 years ago
Can Inserts Be Improved?about 22 years ago
Drug Development Linked More Closely to Diagnosticsabout 22 years ago
In The Spotlight-October 2004about 22 years ago
The High Price of SuccessAdvertisement
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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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