Business · 10/04/2008Updated: 10/17/2026 · 1 min read
FDA Releases Guidance for Human Gene Therapy IND Applications
Summary
The FDA has made available a guidance document outlining recommendations for sponsors and instructions for reviewers on the Chemistry, Manufacturing, and Control (CMC) information required for human gene therapy Investigational New Drug Applications (INDs).
Original source language: Federal Register — Food and Drug AdministrationOpen original release →