Posted by Michael Wonder on 04 Feb 2025
Comparison of clinical evidence submitted to the FDA and EMA for cell and gene therapies
3 February 2025 - Harmonisation in regulatory submissions across agencies may support timelier access to innovative treatments, including cell and gene therapies.
The US FDA recently announced the Collaboration on Gene Therapies Global Pilot program aimed at coordinating regulatory review of cell and gene therapy submissions among the FDA, EMA and other regulatory agencies and to align evidence submitted by sponsors.
