|Articles|September 15, 2019
- BioPharm International-09-15-2019
- Volume 2019 eBook
- Issue 3
What’s New in Regulations and Compliance
Regulatory agencies and pharmacopeia organizations revised policies and guidelines in 2019.
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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
BioPharm International
eBook: Regulatory Sourcebook, September 2019
September 2019
Pages: 7–9
Citation
When referring to this article, please cite it as BioPharm International Editors, “What’s New in Regulations and Compliance," BioPharm International Regulatory Sourcebook eBook (September 2019).
Articles in this issue
about 6 years ago
Global Pharmacopoeia Standards: Why Harmonization is Needed (eBook)about 6 years ago
Why Pharmacopoeia Compliance Is Difficult (eBook)about 6 years ago
Why Pharmacopoeia Compliance Is Necessary (eBook)about 6 years ago
Quality Culture Drives Patient Confidence in Drug Productsabout 6 years ago
Biosimilar Quality Requirementsabout 6 years ago
Is it Time to Update cGMPs?about 6 years ago
Regulatory and Standard Setting Organizationsabout 6 years ago
Resources, Guidelines, and Guidance DocumentsNewsletter
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