As the US FDA re-gears to respond to the coronavirus disease (COVID-19) pandemic, the agency’s Center for Biologics Evaluation and Research (CBER) says it will “significantly scale back” lot release activities. In a letter to biological product manufacturers, CBER’s Office of Compliance and Biologics Quality (OCBQ) advises that it will no longer accept biological product samples or lot release protocols in physical form (paper or CD-ROM) at the agency’s headquarters in Silver Spring, MD until further notice. Despite the pause in other lot release activities, CBER says it will continue to prepare reagents for the 2020/2021 influenza season. Learn More