What’s New in Regulations and Compliance

Pharmaceutical Technology, Pharmaceutical Technology-09-15-2019, Volume 2019 eBook, Issue 2
Pages: 6–10

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

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 Pharmaceutical Technology’s September 2019 Regulatory Sourcebook.

Article Details

Pharmaceutical Technology
eBook: Regulatory Sourcebook, 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," Pharmaceutical Technology Regulatory Sourcebook eBook (September 2019).