Event

HOT TOPIC Discussion: FDA Updates EUA for CCP in Response to New Data (21EL-605) – Free for everyone!

Please note: AABB reserves the right to make updates to this program.

Live Program Date: Tuesday, February 9, 2021 - On-Demand Available
Program Number: 21EL-605

Registration

This on-demand hot topic discussion is complimentary to all but registration is required. After signing up on GoToWebinar the video will immediately begin to play.

  • Program Description

    The Food and Drug Administration announced a revision to its Emergency Use Authorization (EUA) for COVID-19 convalescent plasma (CCP) following an evaluation of new scientific data. The agency noted that since the original EUA was released in August 2020, various clinical trials have been conducted, leading to more data and a better understanding of the optimal use of CCP as a treatment option for patients with COVID-19. In response, FDA’s revised EUA allows only high-titer CCP for the treatment of hospitalized patients early in the course of the disease, as well as for hospitalized patients who have impaired humoral immunity and cannot produce an adequate antibody response.

    Notably, under the revised EUA, the use of low-titer CCP is no longer authorized as a treatment option. According to the FDA, this change is based on data from clinical trials, which “have not shown evidence to demonstrate that low titer convalescent plasma may be effective in the treatment of hospitalized patients with COVID-19.” Join FDA representatives Peter Marks, MD, PhD, and Nicole Verdun, MD to have your questions answered!

    Moderator: Sharon Carayiannis, MT(ASCP)HP, Senior Director, Regulatory Affairs, AABB
    Speakers:

    • Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, Food & Drug Administration
    • Nicole Verdun, MD, Director, Center for Biologics Evaluation and Research Office of Blood Research and Review, Food & Drug Administration

    Continuing Education Credit

    Continuing education credit is not offered for this program.

    Register