FDA Announces Decision for a Tissue-based Product for use in Dogs

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.