A US Food and Drug Administration (FDA) official discussed the agency’s recent efforts to spur the development of cell and gene therapies during a workshop at the Drug Information Association’s (DIA) Global Annual Meeting on 27 June.
Kimberly Schultz, the chief of Gene Therapy Branch 4 in the Office of Therapeutic Products (OTP) discussed these efforts and how the agency is expanding its outreach to improve the quality of applications being submitted to the agency.
To date, FDA has approved a total of 30 cell and gene therapies, a jump from the 23 approved in 2022.
To facilitate the development of these therapies, FDA will can apply its expedited pathways, such as Regenerative Medicine Advanced Therapy Designation (RMAT) designation, breakthrough therapy designation (BTD) and accelerated approval.
Recent efforts to spur such development efforts include a recent office reorganization, which provides “additional flexibility in our ability to respond to the growth that is happening in the field and to better able to meet the needs of patients and developers.”…
