FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
News|Articles|October 2, 2004
- Pharmaceutical Technology-10-02-2004
- Volume 28
- Issue 10
Drug Development Linked More Closely to Diagnostics
Author(s)Jill Wechsler
FDA and industry discuss proposals for regulating combination diagnostics, medical devices, and pharmacogenomic-based drug products.
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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
In The Spotlight-October 2004about 22 years ago
October 2004about 22 years ago
The High Price of SuccessAdvertisement
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FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
FDA final guidance defines when companion app output counts as drug labeling and when device-connected or standalone apps belong in prescribing information.
The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.
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