What’s New in Regulations and Compliance

Publication
Article
BioPharm InternationalBioPharm International-09-15-2019
Volume 2019 eBook
Issue 3
Pages: 7–9

Regulatory agencies and pharmacopeia organizations revised policies and guidelines in 2019.

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.

Read this article in BioPharm International’s September 2019 Regulatory Sourcebook.

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
BPebook0919_PharmacopeiaCompendia_Harmonization_225.jpg
Global Pharmacopoeia Standards: Why Harmonization is Needed (eBook)
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Why Pharmacopoeia Compliance Is Difficult (eBook)
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Why Pharmacopoeia Compliance Is Necessary (eBook)
BPebook0919_GuidanceUpdate_225.jpg
What’s New in Regulations and Compliance
BPebook0919_regulatoryUpdate_peters_225.jpg
Quality Culture Drives Patient Confidence in Drug Products
BPeBook0919_Regulatory_Biosimilars_125.jpg
Biosimilar Quality Requirements
BPeBook0919_cGMPs.jpg
Is it Time to Update cGMPs?
BPebook0919_Resources_Organizations_225.jpg
Regulatory and Standard Setting Organizations
BPebook0919_Resources_Guidelines_225.jpg
Resources, Guidelines, and Guidance Documents

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