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).

 

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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)
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What’s New in Regulations and Compliance
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Quality Culture Drives Patient Confidence in Drug Products
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Biosimilar Quality Requirements
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Is it Time to Update cGMPs?
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Regulatory and Standard Setting Organizations
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Resources, Guidelines, and Guidance Documents
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