|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).
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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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