ARM Statement on FDA's PDUFA Commitment Letter

Washington, DC – August 24, 2021

ARM commends FDA for, among other things, the inclusion of two priority elements supported by ARM in the agency’s Prescription Drug User Fee Act VII (PDUFA) commitment letter that will advance cell and gene therapy.

In the letter, FDA pledges to strengthen staff capacity and capability to meet the growing challenges and demands of the cell and gene therapy field. This would help to ensure that FDA has the staff and expertise necessary for the timely review of investigational new drug (IND) applications and biologics licensing applications (BLA) and other communications with sponsors.

In addition, according to the letter, FDA will focus on enhancing support for Chemistry, Manufacturing, and Control (CMC) development and facilitating the CMC readiness of products with accelerated clinical development timelines. In the rapidly advancing cell and gene therapy sector, CMC-related requirements have contributed to delays in the clinical trial and approval process.

As the pipeline for these life-changing therapies continues to grow, ARM supports these commitments from FDA to ensure life-changing treatments can reach patients sooner.