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U.S. Department of Health and Human Services

Drugs

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Drug and Biologic Approval Reports

 

On June 30, 2003, FDA transferred some of the therapeutic biological products that had been reviewed and regulated by the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER). CDER now has regulatory responsibility, including premarket review and continuing oversight, over the transferred products. In regulating the products assigned to them, CBER and CDER will consult with each other regularly and whenever necessary. The links below contain tables that consist of drug and biologic approvals by CDER only. For CBER biologic approvals, please visit: CBER Approvals by Year

NDA Approvals by Therapeutic Potential and Chemical Type

IND Reports

 

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Fast Track Reports

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