FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
News|Articles|September 25, 2019
- Pharmaceutical Technology-09-15-2019
- Volume 2019 eBook
- Issue 2
What’s New in Regulations and Compliance
Regulatory agencies published guidelines to advance drug development, streamline submission processes, and promote biosimilars.
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FDA issued guidance documents that address patient-centric drug development, biosimilars, and a variety of biologics application guidelines. The US Pharmacopeial Convention (USP) also proposed some changes to monographs. A few notable actions taken this year are reviewed.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook, September 2019
September 2019
Pages: 6–10
Citation
When referring to this article, please cite it as Pharmaceutical Technology Editors, “What’s New in Regulations and Compliance," Pharmaceutical Technology Regulatory Sourcebook eBook (September 2019).
Articles in this issue
about 7 years ago
Quality Culture Drives Patient Confidence in Drug Productsabout 7 years ago
Generics: Getting Beyond “File First, Figure it Out Later”about 7 years ago
Global Pharmacopoeia Standards: Why Harmonization is Needed (eBook)about 7 years ago
Why Pharmacopoeia Compliance Is Difficult (eBook)about 7 years ago
Why Pharmacopoeia Compliance Is Necessary (eBook)about 7 years ago
Resources, Guidelines, and Guidance Documentsabout 7 years ago
Regulatory and Standard Setting OrganizationsAdvertisement
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