What is a New Animal Drug Application?

A New Animal Drug Application (NADA) is a formal proposal submitted to the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) to request approval for a new animal drug. The primary purpose of a NADA is to ensure that a new veterinary drug is safe and effective for its intended use, and that it is manufactured in accordance with federal quality standards. This application is critical for maintaining the health of animals and ensuring public safety when products from treated animals are used for human consumption.

Importance of NADA

There are 3 types of NADAs: NADA, abbreviated NADA (ANADA) and conditional NADA (CNADA). According to the Federal Food, Drug and Cosmetic Act, a new animal drug shall not be approved for sale unless it is the subject of a NADA, ANADA, or there is a CNADA in effect.

• NADA: is used to obtain new animal drug approval
• ANADA: is used to obtain generic new animal drug approval
• CNADA: is used to seek conditional approval for a new animal drug; for this, an applicant should be able to demonstrate a “reasonable expectation of effectiveness.

What are the regulatory challenges surrounding NADAs?

There are many regulatory challenges surrounding a NADA with the US FDA. For example, sponsors face challenges in meeting the Agency’s stringent safety and efficacy standards which can often lead to the need for additional or extensive pre-clinical and/or clinical studies in order to demonstrate that the drug is effective and safe to use in the intended animal species. This process can be significantly costly and time-consuming especially for new compounds or therapies.

Sponsors also face difficulties in navigating the regulatory pathways and requirements which can be complex. This also includes providing the required CMC data, product labelling information- all of which must be compliant to US FDA’s guidelines and regulations. Ensuring compliance with veterinary drug approval processes is challenging compared to human drug approval processes as understanding the specific requirement for different animal species adds further complexities. For example, requirements are different for food-producing animals compared to companion animals.

What is the approval process for a NADA?

The US FDA recommends a phased review process. This requires a new animal drug sponsor to provide information and data which supports the requirements of the technical sections for “incremental review” that falls under the investigational new animal drug file. Once these requirements are met, sponsors can submit an administrative NADA that is reviewed by the US FDA within 60 days. This process allows more interaction between the sponsor and CVM which is important for the development of novel animal products.

Non-US sponsors will require a US agent for all NADA submissions on behalf of the sponsor.