Center for Veterinary Medicine
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Table of Contents

2001 Sig. Approvals Arrow
Frequently Requested Arrow
PPP Manual Index Arrow
Medicated Feed Mill Arrow
Regulatory Activity Arrow
Letters to Pharmaceutical Arrow
Veterinary CPG Manual Arrow
Veterinary Master Files Arrow
VMAC Arrow
EFOIA Reading Rooms Arrow


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FOI Summaries

Freedom of Information Summaries (Includes Abstracts) Section 1

Arrow NADA Numbers 000-000 - 139-999

Freedom of Information Summaries (Includes Abstracts) Section 2

Arrow NADA Numbers 140-000 - 149-999

Freedom of Information Summaries (Includes Abstracts) Section 3

Arrow NADA Numbers 200-000 - 200-999

 

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 swd, October 22, 2004 3:28 PM ET

www dot healthfinder dot gov Link to FirstGov




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FDA Logo links to FDA home page HHS Logo links to Department of Health and Human Services website U.S. Food and Drug Administration Center for Veterinary Medicine FDAMA Antimicrobial Resistance Biotechnology Aquaculture Food Safety BSE Guidance Documents Green Book Freedom of Information link to the FDAMA page link to the Antimicrobial Resistance page link to the Biotechnology page link to the Aquaculture page link to the Food Safety page libk to the BSE page link to the Guidance Documents page link to the Green Book page link to the Freedom of Information page