FDA makes decision for tissue-based canine product
The decision was made based on reviews from safety and quality data and information reviews
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The FDA announced that it has made a risk-based decision based on reviews of safety and quality data and information for a canine leukoreduced allogeneic pooled freeze-dried platelet-rich plasma (PrecisePRP Canine; VetStem). The therapy is a prescription product because a professional is required to administer, provide post-treatment care, monitor the product's safe use, and treat any adverse effects.1 Based on the findings at this time, the FDA does not expect VetStem to submit an application for approval before marketing.
According to an FDA release, PrecisePRP Canine provides dogs with a species-specific source of concentrated platelets in plasma used for an intra-articular injection going directly into a dog’s joint.1 At this time, this is the first animal cell, tissue, and cell-and-tissue-based product (ACTP) intended for intra-articular use to undergo reviews from the FDA and receive this determination.
Before this review, the FDA had not reviewed animal platelet-rich plasma products to be available for veterinarians. All ACTPs are maintained by the FDA’s list located on its websites to show which have been evaluated for potential risks. For PrecisiePRP Canine, the FDA performed an evaluation of potential risks associated with ACTPs, including infection and reaction from contamination or other product quality deviation risks. The FDA concluded that the PrecisePRP Canine developer properly identified and appropriately mitigated potential risks associated with the product and has no additional safety concerns.
The FDA also investigated the potential risk of the environment from marketing PrecisePrP Canine, and no hazards to the environment were identified and the product is attained from tissues that are present in most animals naturally.1 The FDA disclosed that the product is not expected to be used in a large quantity of animals at one time in a singular geographic location and is intended for non-food-producing animals only.
The FDA's determination was provided to VetStem, Inc.
Reference
FDA announces decision for a tissue-based product for use in dogs. News release. US Food and Drug Administration. April 26, 2024. Accessed May 1, 2023. https://www.fda.gov/animal-veterinary/cvm-updates/fda-announces-decision-tissue-based-product-use-dogs?utm_medium=email&utm_source=govdelivery
