FDA Extends Enforcement Discretion Period in Revised CCP Guidance

November 20, 2020

FDA extended the temporary enforcement discretion period for distribution of investigational COVID-19 convalescent plasma (CCP) through Feb. 28, 2021, as requested by AABB in a Nov. 2 joint letter, along with America’s Blood Centers and the American Red Cross. This new information is found in the updated Investigational COVID-19 Convalescent Plasma guidance

AABB appreciates FDA's commitment to providing timely guidance to support response efforts to this pandemic, which the agency states “should provide blood establishments adequate time to develop the necessary procedures to manufacture COVID-19 convalescent plasma under the conditions of the EUA, and if unable to develop such procedures, only administer investigational convalescent plasma under an IND.”

AABB has posted an updated Toolkit for COVID-19 Convalescent Plasma under Emergency Use Authorization with: 

  • A change table to identify all new information.
  • A comprehensive Q&A from AABB’s live sessions with FDA.
  • Flowcharts to map the path for use of CCP under EUA and IND.
  • A proposed approach to avoid unnecessary donor deferrals after vaccination for COVID-19. 

Contact regulatory@aabb.org with questions.