CDER and CBER take steps to increase EUA transparency

On November 17, USA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration announced additional steps to increase transparency regarding CDER and CBER’s review of the scientific information supporting the issuance of or revisions to an emergency use authorizations (EUAs) to promote public confidence in FDA’s scientific process and the appropriate use of authorized products.

They say their intention is to be as transparent as possible under the law about the scientific basis for recommending that a drug or biological product be authorized for emergency use under the Federal Food, Drug and Cosmetic Act.

In the future, when a CDER-regulated or CBER-regulated product is authorized for emergency use, they intend to make public to the extent appropriate and permitted by law the Center’s review of the scientific data and information supporting their recommendation to issue, revise, or revoke the EUA.