What’s New in Regulations and Compliance
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
Citation
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).
Guidance on Quality Culture Standards
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