Get the free Freedom of Information Summary Original New Animal Drug Application NADA 140-955 - fda

This document provides a detailed summary of the approval for the animal drug application of a combination medication used in growing turkeys for the prevention of coccidiosis and improvement of feed

How to fill out dom of information summary

How to fill out Freedom of Information Summary Original New Animal Drug Application NADA 140-955

1. Gather necessary information about the animal drug, including the drug's name, active ingredients, and intended use.
2. Obtain the format guidelines from the FDA for the Freedom of Information Summary (FOI).
3. Complete the required forms, which may include detailed sections on safety, efficacy, and manufacturing processes.
4. Include data and study results that support the drug's approval.
5. Ensure all information is clear, concise, and accessible to the reviewing agency.
6. Review and proofread the summary for accuracy and compliance with FDA requirements.
7. Submit the FOI summary along with the New Animal Drug Application (NADA) to the FDA.

Who needs Freedom of Information Summary Original New Animal Drug Application NADA 140-955?

1. Animal drug manufacturers seeking approval for new animal drugs.
2. Regulatory affairs professionals involved in the submission process.
3. Veterinary practitioners interested in the safety and efficacy of new animal drugs.
4. Researchers and stakeholders in the animal health industry.

People Also Ask about

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 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 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 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.

What is the Animal Drug Availability Act?

The Animal Drug Availability Act (H.R. 2508) (“ADAA”), signed by the President on October 9, 1996, amended the Federal Food, Drug, and Cosmetic Act to provide new flexibility to the way FDA regulates new animal drugs and medicated feeds.

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 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.

For pdfFiller’s FAQs

What is Freedom of Information Summary Original New Animal Drug Application NADA 140-955?

The Freedom of Information Summary (FOIS) for the Original New Animal Drug Application (NADA) 140-955 provides a detailed overview and summary of the data supporting the approval of a specific new animal drug, including its safety and effectiveness.

Who is required to file Freedom of Information Summary Original New Animal Drug Application NADA 140-955?

The applicant or sponsor who seeks approval for a new animal drug is required to file the Freedom of Information Summary as part of the NADA submission process.

How to fill out Freedom of Information Summary Original New Animal Drug Application NADA 140-955?

To fill out the FOIS for NADA 140-955, the applicant must provide specific information including the drug's name, intended use, target species, summary of studies, and safety data, while ensuring compliance with FDA guidelines.

What is the purpose of Freedom of Information Summary Original New Animal Drug Application NADA 140-955?

The purpose of the FOIS is to provide transparency and access to information regarding the safety and efficacy of new animal drugs, allowing stakeholders to understand the basis for the FDA's approval.

What information must be reported on Freedom of Information Summary Original New Animal Drug Application NADA 140-955?

The FOIS must report information such as the drug description, dosing regimen, administration route, summary of laboratory and clinical studies, safety data, effective ingredients, and any pertinent manufacturing information.