ARTICLES BY STEPHEN MASON
An Overview Of FDA’s New Guidance On Long-Term Follow-Up After Administration Of Gene Therapies
The FDA recently issued for public comment six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy.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.
FDA’s New Guidance On Replication Competent Retrovirus Testing During Gene Therapy Manufacture
The draft guidance document provides recommendations regarding the testing for RCR during the manufacture of retroviral vector-based gene therapy products, and for follow-up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.