The American Association of Equine Practitioners (AAEP) is encouraging its members to comply with a recent FDA guidance document that outlined regulatory requirements for animal cell-based products (ACPs).
Source: Modern Equine Veterinarian, Issue 2, 2017, page 8.
There is considerable concern about the impact on the equine veterinary industry,” Said Christopher E. Kawcak, DVM,PhD, ACVS, ACVSMR, of the Equine Orthopaedic Research Center at Colorado State University . “If you want to produce these, and market and sell them, and charge for them, you need a new [animal] drug application to do that. It can cost several million dollars, and you have to prove safety and efficacy, which is not always easy to do,” he said.