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