REGULATORY UPDATE: CBER To Resume Normal Operations in 2023

The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) plans to resume normal operations as the agency enters 2023, according to an updated Letter to Sponsors, Applicants and Regulated Entities on COVID-19 released June 9. For the remainder of calendar year 2022, however, CBER will continue to prioritize resources for COVID-19 regulatory work over non-COVID-19 work.

The letter also outlines plans for CBER meetings, which remain in virtual format. “CBER will continue to assess the feasibility of holding in-person meetings at FDA facilities,” the letter states. “Sponsors and applicants should monitor the CBER website for updates regarding in-person meetings.”

In addition, FDA announced that the CBER Document Control Center will process paper and electronic media submissions sent via U.S. mail or courier effective immediately. Submissions may be sent through the Electronic Submission Gateway or by email in some cases. Please see the updated letter for additional instructions.

FDA updated the Coronavirus (COVID-19) and CBER-Regulated Biologics web page to reflect this new information.