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 New Animal Drug Application (NADA) or Abbreviated New Animal Drug Application (ANADA) and forms the basis for the Agency's approval of an NADA or ANADA. 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, ANADA, 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 new animal drug
- Indications for use, dose 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 cannot accept FOIA requests via E-mail.
Environmental Assessments (EAs) and Findings of No Significant Impact (FONSIs), where applicable, may be found listed by the established name of the active pharmaceutical ingredient.