ARTICLES BY STEPHEN MASON
An Overview Of FDA’s New Guidance On Long-Term Follow-Up After Administration Of Gene Therapies7/27/2018
The FDA recently issued for public comment six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy.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 Manufacture7/25/2018
The draft guidance document provides recommendations regarding the testing for RCR during the manufacture of retroviral vector-based gene therapy products, and for follow-up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.