Gene Therapies: Safety, CMC Draft Guidances Coming From US FDA In 2018
Lengthy safety registries, extensive premarket testing for replication competent retrovirus, and manufacturing submission advice likely; pending CBER documents informed by review and approval of Novartis' Kymriah, Kite's Yescarta, and Spark's Luxturna.
The US FDA's Center for Biologics Evaluation and Research (CBER) plans to update a suite of guidance documents related to gene therapy manufacturing and safety in 2018.
The new draft guidance documents appear aimed at replacing existing guidelines issued from 2006 to 2008
