September 16, 2021
FDA’s Centre for Veterinary Medicine deems TriviumVet’s feline HCM program eligible for expanded conditional approval pathway
The U.S. Congress granted the FDA a limited extension of the conditional approval pathway for certain new veterinary drugs as part of the FDA’s 2018 new approval of the Animal Drug User Fee Act (ADUFA). The conditional approval allows drug sponsors to legally market a product, after it has been demonstrated that the medicinal product is safe, has been manufactured …