FDA announces changes at OTAT

Oct. 4, 2022
Regulatory update.

The Food and Drug Administration has retitled and elevated the Office of Tissues and Advanced Therapies (OTAT) as part of a reorganization within the Center for Biologics Evaluation and Research (CBER), the agency announced Sept. 28. 

As of Sept. 16, FDA retitled OTAT to the Office of Therapeutic Products (OTP) and designated OTP as a “Super Office.”  According to the agency, the changes will improve OTP’s functional alignment, increase review capabilities and enhance expertise on new cell and gene therapies.

“The reorganization will also position OTP to focus on commitments, including those negotiated with industry in the prescription drug user fee agreement (PDUFA) for FY 2023-27, and other key priorities that protect public health,” according to the Federal Register notice.

AABB release