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 15, 2020
- Pharmaceutical Technology-10-15-2020
- Volume 2020 eBook
- Issue 3
Regulatory and Standard Setting Organizations
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
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Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
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Articles in this issue
about 6 years ago
Enhancing Process Validation for Solid Oral Dosage Forms: Part 2about 6 years ago
Due Diligence Assessment of CMC Activitiesabout 6 years ago
Tackling Cybersecurity Challenges in Legacy Systemsabout 6 years ago
Ending ‘Magical Thinking’ in Compoundingabout 6 years ago
Viral Vector API Characterization of Product-Related Impuritiesabout 6 years ago
Strong Quality Culture: A How-To for Busy Managersabout 6 years ago
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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.
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.
FDA final guidance defines when companion app output counts as drug labeling and when device-connected or standalone apps belong in prescribing information.
Science, circularity, regulation, and technology are reshaping how the industry develops packaging for medicines.
Panelists on PharmTech AI Pulse Check debate SURPASS, a new digital-twin trial program, regulatory acceptance, and the data-cleanup burden it will create.
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.
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