ACTPs that are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or are intended to affect the structure or any function of the animal generally meet the definition of a new animal drug. These ACTPs contain, consist of, or are derived from cells or tissues and are intended for implantation, transplantation, infusion, or transfer into an animal recipient. FDA’s Center for Veterinary Medicine’s (CVM’s) oversight of ACTPs includes, where appropriate, an evaluation of safety and effectiveness with a particular focus on safety and is based on risk (see Cell-Based Products for Animal Use guidance (GFI 218)).
Sponsors are generally required to have an approved new animal drug application before marketing ACTPs. Although ACTPs require an approved NADA, conditional approval, or index listing to be legally marketed, FDA recognizes that certain ACTPs pose a lower risk to human and animal safety than other categories of ACTPs. For example, Autologous Type II products are a lower risk when used in nonfood-producing animals and are, therefore, a lower enforcement priority.
Persons marketing lower risk ACTPs without approval or index listing should be aware that the agency may take enforcement action against them at any time when the agency concludes it is necessary to further the purposes of the Federal Food, Drug, and Cosmetic Act. Persons developing, manufacturing, or marketing ACTPs should contact CVM's Office of New Animal Drug Evaluation to discuss how their product is regulated.
CVM intends to prioritize use of its resources for certain ACTPs in a manner that is protective of human and animal health, is based on risk and informed by available science and data. Below is a list of those ACTPs that CVM has determined are lower risk following our review of product-specific information.
StablePlate RX®, canine allogeneic lyophilized platelets, BodeVet, Inc., a subsidiary of Cellphire Therapeutics, Inc.