AM20-33: COVID-19 Convalescent Plasma (CCP) -- The Regulatory Landscape

Description

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

Learning Objectives:

• Review current regulatory process for CCP
• Describe current regulations regarding CCP
• Describe current regulatory landscape for CCP

Speaker(s):

• Dr. Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, FDA
• Dr. Nicole Verdun, MD, Director, Office of Blood Research and Review, FDA

Disclosures

• Peter Marks, MD, PhD : Nothing to disclose
• Nicole Verdun, MD : Nothing to disclose