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).
