What Is an Investigational New Animal Drug (INAD)?
A Regulatory Pathway for Veterinary Drug Development
Veterinary medicinal products require rigorous testing to ensure that they are safe and effective for use in animals. In the United States, the development of new animal drugs is governed by the U.S. Food and Drug Administration (FDA) under the Center for Veterinary Medicine (CVM). One of the major regulatory tools that facilitate this process is the Investigational New Animal Drug (INAD).
An Investigational New Animal Drug (INAD) is a regulatory dossier that enables a sponsor to lawfully distribute and use an unapproved animal drug for investigational purposes. The INAD facilitates the accumulation of information regarding safety, efficacy, dosage, and manufacturing, which is necessary for approval of a New Animal Drug Application (NADA) or Abbreviated NADA (ANADA).
Unlike an application, an INAD is an umbrella file that remains active throughout the development of life cycle of the investigational animal drug.
When Is an INAD Required?
An INAD is required when:- Conducting clinical investigations of unapproved animal drugs
- Collecting data to support FDA approval
- Shipping investigational animal drugs across state lines
Key Components of an INAD
Investigational Plan Aims and protocols of the study, target animal species, and dosage regimens. Safety and Effectiveness Data Data from laboratory studies, target animal safety studies, and field studies. Manufacturing Information Information on formulation, manufacture, quality control, and stability. Environmental and Human Food Safety Evaluations for food-producing species, including residue and withdrawal information.Importance of INAD Compliance
Effective management of INAD is essential for regulatory compliance, animal welfare, and efficient veterinary drug development.
How Masuu Global Can Help
Masuu Global offers specialized assistance in INAD establishment, data management, regulatory affairs, and interactions with the FDA-CVM to enable timely veterinary drug approvals for sponsors.