ARTICLES BY STEPHEN MASON
-
![FDA Logo]( "An Overview Of FDA’s New Guidance On Long-Term Follow-Up After Administration Of Gene Therapies")
An Overview Of FDA’s New Guidance On Long-Term Follow-Up After Administration Of Gene Therapies7/27/2018The FDA recently issued for public comment six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy. This is the third article in a six-part series.
-
![Virus-DNA]( "FDA’s New Guidance On Replication Competent Retrovirus Testing During Gene Therapy Manufacture")
FDA’s New Guidance On Replication Competent Retrovirus Testing During Gene Therapy Manufacture7/25/2018The draft guidance document provides recommendations regarding the testing for RCR during the manufacture of retroviral vector-based gene therapy products, and for follow-up monitoring of patients who have received retroviral vector-based gene therapy products.
Stephen Mason
Stephen Mason is senior VP of regulatory policy in the Drug and Biological Products group at Greenleaf Health, Inc. He has experience from FDA, Capitol Hill, and within the innovator and generic pharmaceutical industries. He specializes in regulatory and legislative policy development and analysis. You can reach Mason at stephen.mason@greenleafhealthllc.com.