During this live Q&A session, FDA’s Peter Marks and Nicole Verdun will answer questions about the regulatory framework for COVID-19 Convalescent Plasma (CCP). We will be taking live questions during the session and will try to get to as many of them as possible.
Topics for discussion include:
- Timeline for implementation of the EUA. - FDA’s use of temporary enforcement discretion . - An update on the testing and labeling collections as high-titer or low-titer. - Inventory management options such as retesting units collected under the National Expanded Access
Program for use under the EUA or for shipment to the Surge Capacity Storage
Review current regulatory process for CCP
Describe current regulations regarding CCP
Describe current regulatory landscape for CCP
Director, Center for Biologics Evaluation and Research,