FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
|Articles|September 2, 2005
- Pharmaceutical Technology-09-02-2005
- Volume 29
- Issue 9
FDA Faces Multiple Challenges
Author(s)Jill Wechsler
Commissioner Crawford’s top priority is to restore public confidence in FDA oversight of drug safety and quality.
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Articles in this issue
about 21 years ago
Securing the Supply Chain With RFIDabout 21 years ago
Applications of Poly(ethylene in Drug Delivery Systems: Part IIabout 21 years ago
Analytical Method Equivalency: An Acceptable Analytical Practiceabout 21 years ago
September 2005about 21 years ago
Pilots and Partnerships Move RFID Forwardabout 21 years ago
Reshaping CMC Development Servicesabout 21 years ago
Wash. Rinse. Repeatabout 21 years ago
Outsourcing Atrophy: A Cautionary TaleAdvertisement
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FDA final guidance defines when companion app output counts as drug labeling and when device-connected or standalone apps belong in prescribing information.
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.
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.
Jaenisch, Muraru, and Pandey discuss new skills for QC and regulatory teams, plus patient trust, as new approach methodologies reshape pharma.
Nine duloxetine recalls since 2024 show why generic drug manufacturers need route-level nitrosamine risk assessment, not end-product testing alone.
Ravi Kiran Kaja, PhD, explains how USP’s industry-wide initiative aims to build confidence in trace-level extractables and leachables results.
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