FOIA Drug Summaries

A Freedom of Information (FOI) Summary summarizes the safety and effectiveness information submitted by the sponsor to support the approval of an original or supplemental NADA and forms the basis for the agency's approval of an NADA. This information is released by the Food and Drug Administration (FDA) when the approval is published in the Federal Register in accordance with 21 CFR section 514.1(e).

The intent of the FOI Summary is to inform the public by providing the basis on which the Agency approved the NADA or supplement. Summaries are provided for pivotal and supplementary studies supporting safety and effectiveness of the drug in the target animal as well as human food safety.

The FOI Summary includes:

• General information about the approved drug
• Indications for use, dosage form, route of administration
• Explanation of the recommended dosage
• The Agency's conclusions

 
If the FOI Summary is not electronically available 

To obtain a copy of an FOI Summary that is not electronically available, please submit a written Freedom of Information Act (FOIA) request. Information on how to submit an FOIA request can be found on the "How to make a FOIA Request" webpage. CVM can not accept FOI requests via E-mail.