On June 11, the U.S. Food and Drug Administration issued a final Guidance for Industry describing the agency’s current thinking on cell-based products for animal use that meet the definition of a new animal drug. A cell-based product, including an animal stem cell-based product, that is intended to diagnose, cure, mitigate, treat, or prevent disease in animals, or is intended to affect the structure or function of the animal, generally meets the definition of a new animal drug.

The final guidance updates the agency’s draft guidance by incorporating feedback from public comment. In particular, the final guidance clarifies that it is directed at facilities and individuals manufacturing and marketing such products, including animal stem cell-based products, for animal use. Although it focuses on animal stem cell-based products meeting the definition of a new animal drug, this guidance also applies to other cell-based products meeting the definition of a new animal drug.

The FDA is aware that many potential cell-based products may be produced as veterinary therapies. Developers of such products for animal use have asked how the agency intends to regulate these products.

Cell-based products that meet the definition of a new animal drug are subject to the same statutory and regulatory requirements as other new animal drugs, including the requirements for current good manufacturing practices (cGMPs) and labeling. To be legally marketed, a new animal drug requires an approved or conditionally approved new animal drug application (NADA) or index listing, unless it meets a statutory exemption. At this time, the FDA believes an approved NADA will be the appropriate regulatory pathway for most cell-based products.

This final guidance:

·         Clarifies FDA’s position that it has jurisdiction over cell-based products meeting the definition of a new animal drug;

·         Clarifies FDA’s current thinking on how existing regulations apply to cell-based products;

·         Establishes a common vocabulary, including definitions, for cell-based products;

·         Establishes a risk-based category structure for cell-based products; and

·         Encourages industry to communicate and interact with FDA early in product development.

Find more information on the FDA Center for Veterinary Medicine website