The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research at FDA plan to take 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.
The goal 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, FDA intends 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, FDA also intends 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.
