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|September 2, 2002
- Pharmaceutical Technology-09-02-2002
- Volume 26
- Issue 9
Attack Mounts on Drug Prices
Author(s)Jill Wechsler
Congress debates legislation for a Medicare drug benefit while the industry expresses concerns about import control, drug counterfeiting, and patent rights.
Advertisement
Articles in this issue
about 24 years ago
Innovations of Membrane Chromatography for Biomolecular Purificationabout 24 years ago
New Syringe Designs Combine Prefilled Convenience with Safetyabout 24 years ago
Outsourcing Outlookabout 24 years ago
Spreading of Semisolid Formulations: An Updateabout 24 years ago
Auditing Your ContractorAdvertisement
Related to this article
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.
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.
From AI validation to microstructure imaging, AAPS PharmSci 360 speakers pushed toward faster drug development backed by stronger evidence. Here are PharmTech's biggest takeaways.
Panelists on the PharmTech AI Pulse Check weigh a December AI playbook, EMA/MHRA moves, PCCP accountability gaps, and MCP-ready regulatory guidance.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Signs Point to FDA Shelving Priority Voucher Pilot, Stalling Fast-Track Drug Reviews
2
Our Biggest Takeaways From AAPS PharmSci 360
3
PharmTech AI Pulse Check: Who's Accountable When a Vendor's AI Model Changes?
4
PharmTech’s Weekly Roundup—November 6, 2026: Impurities, Supply Resilience, and AI Accountability
5