Investigational COVID-19 Convalescent Plasma; Guidance for Industry

Investigational COVID-19 Convalescent Plasma; Guidance for Industry

Coronavirus (COVID-19) Update: Daily Roundup September 2, 2020

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: On September 1, 2020, the FDA approved an abbreviated new drug application for cisatracurium besylate USP 20 mg/10mL, which is indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of cisatracurium besylate injection include bradycardia, hypotension, flushing, bronchospasm, and rash. This drug is listed in the FDA Drug Shortage Database. The FDA remains deeply committed to facilitating access to medical products that are experiencing increased demand. As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to 1 Party At A Time for selling an unapproved product with fraudulent COVID-19 claims. The company sells BetterFly, a niacin containing product, with false or misleading claims that the product can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. There are currently no FDA-approved products to prevent or treat COVID-19. FDA requested that 1 Party At A Time immediately stop selling this unapproved and unauthorized product. Consumers concerned about COVID-19 should consult with their health care provider. Today, the FDA updated its guidance, “Investigational COVID-19 Convalescent Plasma,” to provide additional information related to the recently issued Emergency Use Authorization (EUA) for the use of COVID-19 convalescent plasma to treat hospitalized patients with COVID-19. This update includes a discussion regarding FDA’s intent to exercise temporary enforcement discretion regarding the IND requirements for the use of this product when blood establishments, hospitals, and health care providers collect plasma that does not meet the Conditions of Authorization of the EUA. The revised guidance continues to provide recommendations for health care providers who wish to administer and study convalescent plasma under an Investigational New Drug Application. In addition, the agency updated the web page, “Recommendations for Investigational COVID-19 Convalescent Plasma,” which also provides this information.

Testing updates: To date, the FDA has currently authorized 238 tests under EUAs; these include 192 molecular tests, 42 antibody tests, and 4 antigen tests.