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

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.