FDA's CMC Guidance for Investigational Gene Therapies Reflects Broader CMC Evolution

Executive Summary New draft document addresses issues with applying quality-by-design to gene therapies, accommodating the Common Technical Document format, as well as drug substance, cell bank and contract manufacturing issues. US FDA's Denise Gavin offers insights on agency thinking at gene therapy conference. Register for our free email digests:

Executive Summary

New draft document addresses issues with applying quality-by-design to gene therapies, accommodating the Common Technical Document format, as well as drug substance, cell bank and contract manufacturing issues. US FDA's Denise Gavin offers insights on agency thinking at gene therapy conference.

Register for our free email digests:

Source: pink.pharmamedtechbi.com