What’s New in Regulations and Compliance

BioPharm International, BioPharm 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).