CBER outlines another slim guidance agenda for 2022
For the second year in a row, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has laid out a relatively slimmed-down guidance agenda, featuring just 13 draft and final guidances the center plans to issue in 2022.The list is down slightly from the initial 14 guidances that made the list in 2021, and down more significantly from the 31 guidances the center listed in 2020. As with previous years, there are only a handful of new guidances appearing on the agenda, with most of them being carried over from the previous year. (RELATED: CBER lays out scaled-down guidance agenda for 2021, Regulatory Focus 2 February 2021; CBER plots new draft guidance in 2020 on genome editing, CAR-T therapies, Regulatory Focus 14 February 2020)
As in other years, the center notes that it is not “bound” by the topics on the list and that it is not required to issue every document that appears on it.
Some of the notable guidances that appeared on the list last year and have yet to be published include draft guidances on the development of human gene therapy products incorporating genome editing and chimeric antigen receptor (CAR) T cell therapies.
Two new draft guidances appear on the list for 2022: one on a voluntary consensus standards recognition program for regenerative medicines and one on determining donor eligibility for human cells, tissues, and cellular and tissue-based products (HCT/Ps).
CBER also indicates that it plans to finalize its draft guidance on gene therapies for neurodegenerative diseases this year.
Additionally, CBER says it will issue draft guidance on emergency use authorization (EUA) for COVID-19 vaccines. The agency has already issued immediately effective guidance on the topic, but the inclusion of a draft guidance on the agenda could signal that the agency plans to update its guidance and solicit comments on it before finalizing it.
Nearly half of the guidances pertain to blood and blood components, including new draft guidance on blood and blood component donor suitability, eligibility and source plasma quarantine hold requirements. An updated guidance on investigational COVID-19 convalescent plasma that appears on the agenda was issued earlier this month, and an update to the agency’s 2018 guidance on acceptable circulars of information for the use of human blood and blood components is on the agenda for this year. CBER also notes that it intends to issue a Level 2 guidance on the collection of platelets by automated methods “to revise existing recommendations to address statistical sampling plans for process validation.”
FDA
