CAR T-Cell Therapies

We have undertaken an internal review of our processes for drugs and devices and established a revised process for the review of cell and gene therapies that leverages the strengths of both programs. This new process will offer stakeholders the benefits of firm performance targets and well-established processes for conducting reviews and issuing recommendations for drug products, with the additional ethical and implementation considerations that are an important strength of our medical devices processes. The following document provides a brief overview of the new process:

• Review Process for Cell and Gene Therapies