Keynote: FDA’s Efforts to Enhance Gene Therapy Regulatory Interactions

Time: 8:00 am
day: Day One


  • Sharing FDA considerations regarding product manufacturing, including process validation
  • Understanding how regulatory oversight will need to adapt to keep pace with technical innovations in gene therapy manufacturing and development
  • Introducing the CATT meeting – an additional early opportunity to engage with regulators around key issues encountered in the broader development of gene therapies
  • Distinguishing how CATT meetings are different from INTERACT meetings