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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.
eBook: Regulatory Sourcebook, September 2019
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).