FDA Plans to Issue Guidance on Manufacturing Cell and Gene Therapies During the Pandemic

The Center for Biologics Evaluation and Research (CBER) plans to issue guidance that details manufacturing considerations for approved and investigational cellular and gene therapy products during the COVID-19 pandemic.

CBER may issue the pandemic-related guidance before the end of the year, according to an updated version of its planned guidance agenda for 2020, though the agenda does not bind it to that deadline.

The updated document also includes a planned guidance that will outline revised recommendations for biological product deviation reporting for blood and plasma establishments.