Inside FDA’s New Gene and Cell Therapy Guidances
In January 2020, the agency finalized six clinical development and manufacturing guidance documents and drafted new guidance on what would qualify new gene therapies as orphan drugs.
Since 2017, FDA has approved four gene therapies, and regulators expect the number of gene and cell therapies under development to increase dramatically.
Read this article in Pharmaceutical Technology’s March 2020 Regulatory Sourcebook.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook, March 2020
March 2020
Pages: 6–9
Citation
When referring to this article, please cite it as A. Shanley, “Inside FDA’s New Gene and Cell Therapy Guidances," Pharmaceutical Technology Regulatory Sourcebook eBook (March 2020).
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
