FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
|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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Articles in this issue
about 25 years ago
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
Filter Integrity Testing in Liquid Applications, Revisited, Part IAdvertisement
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Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human steps as China's Decree 818 raises the pace.
Cole and Jaenisch dig into AI poisoning in pharma manufacturing, how it hides in plain sight, and who should be accountable for catching it.
Mahmood Majeed, ZS, explains why measurable AI outcomes in pharma supply chain and manufacturing jumped from 29% to 53%, and how GMP limits and GxP validation shape adoption.
Jane Zhang of ETCH Sourcing explains why geopolitics, transparency, and partnership now weigh as heavily as cost and quality when companies choose suppliers, in this episode of Ask the Expert, moderated by Susan J. Schniepp of Nelson Labs.
Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.
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