REGULATORY UPDATE: CBER Establishes Laboratory of Pathogen Reduction Within OBRR

The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) will establish a Laboratory of Pathogen Reduction within the Office of Blood Research and Review, the agency announced this week.

The lab will focus on optimizing new pathogen inactivation technologies, which may potentially reduce or eliminate donor deferral and/or testing requirements. According to FDA, the reorganization will maintain OBRR's two-division structure to ensure operational consistency and build upon recent efficiencies.

CBER also modified the organizational structure for the Office of Vaccines Research and Review (OVRR). Within this office, the Division of Vaccines and Related Product Applications will split into the Division of Review Management and Regulatory Review and the Division of Clinical and Toxicology Review. 

Additional information is available in the Federal Register notice.