Freedom of Information (FOI) Summary Description
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 l(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. The FOI Summary includes general information about the approved drug. The indications for use, dosage form, route of administration, and the recommended dosage are explained. 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. Finally, the Summary provides the Agency conclusions.
If the FOI Summary you require 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 in “ A Handbook for Requesting Information and Records from FDA ”. CVM can not accept FOI requests via E-mail.
Generally the original format followed by the sponsor was used in the preparation of these "electronic" FOIs. Occasionally, formatting changes have been made in order to provide a more readable file on web browsers. In most cases attachments such the currently approved product labeling are not included in these electronic FOIs. Plans are being made to obtain copies of such attachments and include them in future versions of this section.
Web Page Updated by mdt - September 3, 2004, 8:28 AM ET