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 (RELATED: CBER plots new draft guidance in 2020 on genome editing, CAR-T therapies, Regulatory Focus 14 February 2020).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.
Several of the guidances appearing on the list for 2021 have already been issued, including an update to the agency’s guidance on investigational COVID-19 convalescent plasma, manufacturing considerations for licensed and investigational cell and gene therapies during COVID-19 and draft guidance on gene therapies for neurodegenerative diseases. (RELATED: FDA offers first thoughts on neurodegenerative disease gene therapies, Regulatory Focus 7 January 2021; FDA explains convalescent plasma donor eligibility for COVID vaccine recipients, Regulatory Focus 18 January 2021; FDA guides on COVID considerations in cell and gene therapy, Regulatory Focus 20 January 2021).
The four guidances appearing on the list for the first time fall under the tissues and advanced therapies and blood and blood components categories.
This year, CBER says it plans to finalize its guidance on interpreting sameness of gene therapies under the orphan drug regulations as well as update its human cells, tissues and cellular and tissue-based products (HCT/Ps) small entity compliance guidance. CBER is also planning a new draft guidance on studying multiple versions of a cell or gene therapy in a clinical trial.
For blood and blood components, CBER is planning to update its guidance on reducing the risk of Zika virus transmission.
FDA