Get the free Freedom of Information Summary Original New Animal Drug Application NADA 140-865 - fda

This document summarizes the approval of a combination animal drug application for the prevention of coccidiosis in broiler chickens, detailing the components, dosage, effectiveness, animal safety,

How to fill out dom of information summary

How to fill out Freedom of Information Summary Original New Animal Drug Application NADA 140-865

1. Obtain the Freedom of Information Summary (FOI Summary) template from the FDA's website or relevant guidelines.
2. Fill in the title section, including 'Original New Animal Drug Application NADA 140-865'.
3. Provide a summary of the drug's formulation, including active ingredients and their concentrations.
4. Include a detailed description of the drug's intended use, specifying the target animal species and conditions being treated.
5. Summarize the laboratory and clinical studies conducted, highlighting the methodology, results, and conclusions.
6. Document the safety and effectiveness data, emphasizing any side effects or contraindications discovered during trials.
7. Include a risk assessment for the animal population and any relevant human food safety evaluations.
8. Provide any regulatory compliance information and references to compliance with guidelines.
9. Ensure all data presented is clear, concise, and formatted according to FDA requirements.
10. Review and finalize the document before submission, checking for accuracy and completeness.

Who needs Freedom of Information Summary Original New Animal Drug Application NADA 140-865?

1. Veterinary pharmaceutical companies applying for approval of new animal drugs.
2. Research organizations conducting studies related to animal drug efficacy and safety.
3. Regulatory professionals in the animal health industry.
4. Animal healthcare providers requiring information on new treatment options.
5. Veterinary educators and students studying drug approval processes.

People Also Ask about

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 abbreviated new animal drug application Anda?

The Abbreviated New Animal Drug Application (ANADA) process is for the approval of generic copies of new animal drug products that have been previously approved and shown to be safe and effective.

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 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 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 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 NADA 140-865?

The Freedom of Information Summary Original New Animal Drug Application NADA 140-865 is a document created to provide detailed information about an animal drug's approval process, including data on safety and efficacy, manufacturing details, and labeling. It serves as a summary of the original new animal drug application submitted to the FDA.

Who is required to file Freedom of Information Summary Original New Animal Drug Application NADA 140-865?

The sponsor or manufacturer of the new animal drug seeking approval from the FDA is required to file the Freedom of Information Summary Original New Animal Drug Application NADA 140-865.

How to fill out Freedom of Information Summary Original New Animal Drug Application NADA 140-865?

To fill out the Freedom of Information Summary Original New Animal Drug Application NADA 140-865, the applicant must provide specific information including the drug's intended use, target species, dosage, indications for use, labeling information, and data that supports the drug's safety and efficacy.

What is the purpose of Freedom of Information Summary Original New Animal Drug Application NADA 140-865?

The purpose of the Freedom of Information Summary Original New Animal Drug Application NADA 140-865 is to disclose information about the new animal drug to the public, ensuring transparency about the drug's approval process and providing necessary details for veterinarians and consumers.

What information must be reported on Freedom of Information Summary Original New Animal Drug Application NADA 140-865?

The information that must be reported on the Freedom of Information Summary Original New Animal Drug Application NADA 140-865 includes details about the drug's formulation, safety and efficacy data, manufacturing process, labeling, and any adverse reactions observed during clinical trials.