FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
News|Articles|October 15, 2020
- Pharmaceutical Technology-10-15-2020
- Volume 2020 eBook
- Issue 3
Resources, Guidelines, and Guidance Documents
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
Advertisement
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
Read this article in
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
Regulatory and Standard Setting OrganizationsAdvertisement
Related to this article
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.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
FDA Approves Bepirovirsen: Why Oligonucleotide CDMOs Should Take Note
2
OpenAI Bets on Accelerating Drug Development Timelines With Orchestra Bio
3
AAPS PharmSci 360 2026: System Suitability Standards in E&L Testing
4
Nitrosamine Problems and Industry Solutions: PharmTech Explained
5