REGULATORY UPDATE: FDA Issues Updated 2020 Guidance Agenda

September 18, 2020

FDA's Center for Biologics Evaluation and Research (CBER) issued a September update to the 2020 Guidance Agenda. In the “Blood and Blood Components” category, changes reflect the agency’s August updates to the April 2020 HIV and Creutzfeldt-Jakob disease guidance documents, as described in an Aug. 28 Weekly Report article. The agenda also includes the September issue of the investigational COVID-19 convalescent plasma guidance, which superseded a guidance of the same title issued in April and updated in May.

Notably, FDA added a guidance in the “Vaccines” category titled “Emergency Use Authorization for Vaccines to Prevent COVID-19,” with a footnote indicating that the agency “intends to issue a guidance to provide recommendations regarding the data and information needed to support the issuance of an EUA for vaccines to prevent COVID-19.”

FDA did not make changes in the categories of “Tissues and Advanced Therapies” or “Other.” AABB invites members to contact regualtory@aabb.org with questions.