CDER and CBER Announce Additional Steps to Increase Emergency Use Authorization Transparency
On November 17, 2020, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the FDA 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. Our 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, we intend to make public to the extent appropriate and permitted by law the Center’s review of the scientific data and information supporting our recommendation to issue, revise, or revoke the EUA. When an EUA is revised, we also intend to make public to the extent permitted by law the Center’s reviews of the scientific data and information supporting our recommendations to revise the EUA. We intend to post these reviews with other EUA related materials on the FDA website.
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