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.

, September 2019
	September 2019
	Pages: 6–10

	When referring to this article, please cite it as Pharmaceutical Technology Editors, “What’s New in Regulations and Compliance," 

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Pharmaceutical Technology-09-15-2019

Regulatory agencies published guidelines to advance drug development, streamline submission processes, and promote biosimilars. 