FDA Announces Decision for a Tissue-based Product for use in Dogs
April 26, 2024
Today, the U.S. Food and Drug Administration announced it has made a risk-based decision based on its review of safety and quality data and information and does not expect the developer of PrecisePRP Canine (canine leucoreduced allogeneic pooled freeze-dried platelet-rich plasma) to submit an application for approval prior to marketing.
PrecisePRP Canine provides a species-specific source of concentrated platelets in plasma for injection directly into a dog’s joint (intra-articular injection). PrecisePRP Canine is the first animal cell, tissue, and cell- and tissue-based product (ACTP) intended for intra-articular use to undergo FDA review and receive this determination.
Today’s risk-based decision aligns with the FDA’s Animal and Veterinary Innovation Agenda (AVIA), which aims to foster product development and implement smart, risk-based approaches to regulating modern animal and veterinary products, including ACTPs like PrecisePRP Canine. Prior to the FDA’s determination for PrecisePRP Canine, there were no FDA-reviewed animal platelet-rich plasma products available to veterinarians. The FDA maintains a list on its website of ACTPs for which the FDA has evaluated potential risks and determined that it does not expect an application to be submitted for approval prior to marketing.
There is great interest in platelet-rich plasma in both human and veterinary medicine. Applications for platelet-rich plasma in dermatology, ophthalmology, musculoskeletal disease, and other medical fields are under investigation in the scientific community.
In its review of PrecisePRP Canine, the FDA evaluated potential risks associated with ACTPs, such as risk for infections and reactions from contamination or other product quality deviations that may occur during manufacturing. The agency also evaluated the risk for transmitting disease agents from donors to recipients and to people in contact with the product or recipient animals. Reactions, such as injection site inflammation or anaphylaxis, are other potential risks for animals receiving allogeneic ACTPs, such as platelet-rich plasma. The FDA concluded that the developer of PrecisePRP Canine properly identified and appropriately mitigated the potential risks associated with the product, and the FDA has no additional safety concerns.
The FDA also evaluated the potential risk to the environment from marketing PrecisePRP Canine. Hazards to the environment were not identified. The product is derived from tissues naturally present in most animals. The relevant characteristics of the platelets are unaltered. The product is not expected to be used in a large number of animals at one time in one geographic location, and the product is intended for use in non-food producing animals only.
PrecisePRP Canine is a prescription product, because professional expertise is required to properly administer the intra-articular injection, provide adequate instructions for post-treatment care, and monitor the safe use of the product, including treatment of any adverse reactions. Safe handling of animal blood products is standard veterinary practice.
The determination for PrecisePRP Canine was provided to VetStem, Inc.
Additional Resources:
- Risk Assessment Summary for PrecisePRP Canine
- Cell and Tissue Products for Animals
- Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs): Lower Risk ACTPs
- Q&A for Developers of Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs)
- Q&A for Pet Owners on Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs)
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.