The US Food and Drug Administration repeatedly emphasized in the final version of its guidance on chemistry, manufacturing and control information for investigational gene therapies its expectation that sponsors will continually improve manufacturing processes and analytics during development – and that they will update their investigational new drug applications (INDs) accordingly.
US FDA Expects Updates On Investigational Gene Therapy CMC Improvements
Final gene therapy IND CMC guidance clarifies expectations on process evolution, distinguishing drug substances from products, cGMP oversight and more.
