Get the free Freedom of Information Summary Original New Animal Drug Application - fda

This document details the approval of the NADA 141-156 for the combined use of Amprolium and Bacitracin Methylene Disalicylate for developing active immunity to coccidiosis and improving feed efficiency

How to fill out dom of information summary

How to fill out Freedom of Information Summary Original New Animal Drug Application

1. Start by gathering all relevant information about the animal drug being applied for.
2. Complete the Freedom of Information Summary (FOI) cover page with the application title and number.
3. Provide a summary of the drug’s composition, including active ingredients and inactive ingredients.
4. Describe the intended use and target species for the drug.
5. Include a summary of the safety and efficacy data, referencing studies conducted.
6. Detail any regulatory history related to the drug, including previous approvals or denials.
7. Specify labeling information, including dosage and administration instructions.
8. Ensure all sections are clear and concise, making it easy for reviewers to find key information.
9. Review the FOI for completeness before submission, ensuring all required appendices are included.

Who needs Freedom of Information Summary Original New Animal Drug Application?

1. Pharmaceutical companies developing new animal drugs.
2. Veterinarians seeking to understand new treatment options.
3. Regulatory agencies requiring documentation for review and approval.
4. Researchers interested in safety and efficacy data of new animal drugs.
5. Stakeholders involved in animal health and welfare.

People Also Ask about

What is a nada new animal drug application?

NADA - A NADA is used to seek approval of a new animal drug. ANADA - An ANADA is used to seek approval of a generic new animal drug. A generic new animal drug is a copy of an approved new animal drug for which patents or other periods of exclusivity are near expiration.

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 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 one of the most recent approvals for an animal drug?

Drug Approval Information DateApplication NumberProduct Name September 19, 2024 NADA 141-585 Zenrelia (ilunocitinib tablets) September 10, 2024 ANADA 200-774 Tulaject 25 (tulathromycin injection) September 5, 2024 ANADA 200-773 Tulaject 100 (tulathromycin injection) September 5, 2024 ANADA 200-795 CARPROFEN Soft Chewable Tablets18 more rows

What is the Green Book report in the animal drugs?

Green Book Reports The Green Book is a list of most FDA-approved and conditionally approved animal drugs and includes information about patents and marketing exclusivity.

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 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.

For pdfFiller’s FAQs

What is Freedom of Information Summary Original New Animal Drug Application?

The Freedom of Information Summary Original New Animal Drug Application (FOS ONADA) is a document that provides a summary of the data submitted to the FDA for the approval of a new animal drug. It includes information about the drug, such as its safety and effectiveness.

Who is required to file Freedom of Information Summary Original New Animal Drug Application?

Any manufacturer or sponsor seeking FDA approval for a new animal drug is required to file the Freedom of Information Summary Original New Animal Drug Application as part of their submission process.

How to fill out Freedom of Information Summary Original New Animal Drug Application?

To fill out a Freedom of Information Summary Original New Animal Drug Application, applicants should provide detailed information about the drug, including its chemical composition, manufacturing process, proposed labeling, and data supporting its safety and efficacy. Specific guidelines provided by the FDA should be followed.

What is the purpose of Freedom of Information Summary Original New Animal Drug Application?

The purpose of the Freedom of Information Summary Original New Animal Drug Application is to provide transparency by summarizing the regulatory information about the drug, allowing stakeholders, including veterinarians and animal owners, to access critical information about new animal drugs.

What information must be reported on Freedom of Information Summary Original New Animal Drug Application?

The information that must be reported includes the drug's name, active ingredients, dosage form, route of administration, labeling information, pharmacology, target animal safety, effectiveness data, and any adverse effect information observed during trials.