What Is an INAD (Investigational New Animal Drug)?
Investigational New Animal Drug (INAD) is an important aspect in the pharmaceutical and veterinary regulatory environment that facilitates the transfer of innovative animal health products out of the laboratory into the market. An INAD is a regulatory filing by the U.S. Food and Drug Administration (FDA) (via the Center of Veterinary Medicine (CVM)) by which a company or sponsor is permitted to legally transport and test an unapproved new animal drug across state boundaries in order to conduct research.
Why Is an INAD Needed?
Veterinary drugs need to be safe, effective, and of quality before they can be commercialized. Nevertheless, these data will not be possible to produce without controlled studies on animals. INAD offers the legal purpose within which pharmaceutical companies, biotech firms, and research institutions are able to execute:
- Target animal safety studies
- Substantial evidence of effectiveness trials
- Human food safety studies (for food-producing animals)
- Chemistry, Manufacturing, and Controls (CMC) development
- Environmental assessments
Without an INAD file in place, conducting interstate clinical investigations with an unapproved drug would not be permissible under U.S. law.
What Does an INAD Contain?
An INAD submission is not a single application, it is a lifecycle file, which is developed over the lifetime of drug development. It typically includes:
- Drug composition and manufacturing details
- Proposed labeling
- Study protocols and investigational plans
- Safety and efficacy data as they become available
- Regulatory correspondence with the FDA
With the advancement of studies, amendments to the INAD file are made by the sponsors. It is an interactive process that enables continuous contact with regulators, which ensures conformity and reduces regulatory risks in the future during the New Animal Drug Application (NADA) phase.
The Strategic Importance of INAD in Pharma
Based on the pharmaceutical strategy, it is at the INAD stage that regulatory planning is combined with scientific execution. Early alignment of regulations under an INAD can lower delays in the final approval to a great extent. It also assists the sponsors in determining whether there are some missing data when investing a lot in big-scale trials.
In the veterinary pharmaceutical industry, particularly in companion animal, livestock therapeutics, vaccines, or medicated feed additives, the INAD process is the basis of an effective product commercialization effort.
The successful development of veterinary drugs is based on an Investigational New Animal Drug (INAD) allowing legally conductable research and alignment to regulatory standards before approval. This is a route that needs knowledge and accuracy. Masuu Global is a strategic INAD consultancy that assists pharmaceutical and animal health companies to develop solutions and strategic direction in strategic INAD guidance and documentation, as well as regulatory compliance.