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A Freedom of Information (FOI) Summary describes the safety and effectiveness information submitted by the drug company to FDA to support the approval of a New Animal Drug Application (NADA) or Abbreviated New Animal Drug Application (ANADA). Under federal law,¹ FDA must release this information after the agency approves the application.

The FOI Summary provides the public with a summary of the information that FDA used to determine that the NADA or ANADA met the requirements for approval. The document summarizes the studies that the drug company submitted to support the safety and effectiveness of the drug in the target animal species (the animal species the drug is intended for use in). For a drug for a food-producing species, the document also summarizes the human food safety studies that the company submitted to demonstrate that food products made from treated animals are safe for people to eat.

Location of FOI Summaries

FOI Summaries are arranged by application number in Animal Drugs @ FDA.

The FOI Summary includes:

• General information about the approved animal drug;
• The drug’s indications for use, dosage form, and route of administration;
• An explanation of the dosage regimen; and
• The agency's conclusions.

Most recent FOI Summaries begin with an Executive Summary that provides a brief overview of the scientific basis for the approval followed by a more detailed description.

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. Visit the "How to Make a FOIA Request" webpage for more information. FDA cannot accept FOIA requests via e-mail.

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¹ Title 21 of the Code of Federal Regulations, Part 514.11(e)