USA – CBER lays out scaled-down guidance agenda for 2021

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has released its list of draft and final guidances it plans to issue in 2021.
 
The list contains just 14 guidances, half of which will be draft documents, down from 31 guidances in 2020 and 20 guidances in 2019. Of those 14 guidances, only a few are new additions to the list, with the remainder being carried over from the previous year.
 
CBER was able to cross more than 20 guidances off its list in 2020, despite taking on the development and issuance of five guidances related to COVID-19, including guidance on the development and licensure and emergency use authorization of COVID-19 vaccines. (RELATED: CBER plots new draft guidance in 2020 on genome editing, CAR-T therapiesRegulatory Focus 14 February 2020).
 
As was the case last year, CBER says it is not “bound by this list of topics, nor required to issue every guidance document on this list,” and that it is not precluded from issuing guidance beyond the topics that appear on the list…