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This document provides a summary of the approval process for the combination use of MONTEBAN® (Narasin) and TYLAN® (Tylosin phosphate) in broiler chickens for the prevention of coccidiosis and for
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How to fill out Freedom of Information Summary - NADA 141-170
01
Begin by gathering all relevant data related to the drug or product being summarized.
02
Fill out the application form with basic information about the drug, including its indication, proposed labeling, and any previous submissions.
03
Ensure that all safety and efficacy data, including clinical trial results, are accurately represented.
04
Include detailed information on manufacturing processes and quality control measures.
05
Add any additional information requested by the NADA guidelines specific to your submission.
06
Review the completed summary for accuracy and completeness before submission.
Who needs Freedom of Information Summary - NADA 141-170?
01
Drug manufacturers seeking to obtain approval for their veterinary drugs.
02
Regulatory agencies needing a comprehensive overview of the safety and efficacy of a product.
03
Veterinarians looking for information about new drug approvals.
04
Researchers and academics studying veterinary pharmaceuticals.
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What does the FOI do?
Since 1967, the Freedom of Information Act (FOIA) has provided the public the right to request access to records from any federal agency. It is often described as the law that keeps citizens in the know about their government.
What does freedom of information mean in law?
What is FOIA? Since 1967, the Freedom of Information Act (FOIA) has provided the public the right to request access to records from any federal agency. It is often described as the law that keeps citizens in the know about their government.
What is an example of a FOI?
For example: If you want records about a policy matter at the Department of Housing, Planning & Local Government, you must apply to that Department or if you want access to your medical records, you must apply to the appropriate regional FOI Officer in the HSE.
What is the rule of 3 in FOIA?
The FOIA Improvement Act of 2016 codified the “Rule of 3” for posting frequently requested records. Agencies “shall make available for public inspection in an electronic format… copies of all records…that have been requested 3 or more times.”
What is the FOI explained?
The main principle behind freedom of information legislation is that people have a right to know about the activities of public authorities, unless there is a good reason for them not to.
What is the FOI summary?
A Freedom of Information (FOI) Summary provides the public with the key information that FDA used to determine that a New Animal Drug Application (NADA), an Abbreviated New Animal Drug Application (ANADA), or a Conditional New Animal Drug Application (CNADA) met the requirements for approval or conditional approval.
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What is Freedom of Information Summary - NADA 141-170?
The Freedom of Information Summary for NADA 141-170 is a document that provides a summary of information regarding a specific drug application, including its safety and efficacy, to ensure transparency and public access to information.
Who is required to file Freedom of Information Summary - NADA 141-170?
Sponsors of new animal drug applications (NADAs) are required to file the Freedom of Information Summary - NADA 141-170 as part of the regulatory process with the FDA.
How to fill out Freedom of Information Summary - NADA 141-170?
To fill out the Freedom of Information Summary - NADA 141-170, applicants must provide information on the drug's description, intended use, labeling, and data supporting the safety and effectiveness of the drug.
What is the purpose of Freedom of Information Summary - NADA 141-170?
The purpose of the Freedom of Information Summary - NADA 141-170 is to provide the public and other stakeholders with critical information about new animal drugs, promoting transparency and informed decision-making.
What information must be reported on Freedom of Information Summary - NADA 141-170?
The information that must be reported includes the drug's name, active ingredients, species intended for use, dosage forms, administration route, and summaries of significant safety and efficacy data.
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