All Times EDT
Keywords: FDA/CVM, new animal animal drug applications, new generic animal drug applications
The U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) is responsible for reviewing new animal and new generic animal drug applications. The Biostatistics group is in the Division of Scientific Support of the Office of New Animal Drug Evaluation (ONADE), led by Ms. Laura Stets, and consists of 3 teams. The 3 Biostatistics Teams evaluate study protocols and review results from studies investigating the effectiveness and safety of therapeutic and production drugs including animal bioengineering and cellular therapies. Team 1 is led by Dr. Xiongce Zhao and is responsible for reviewing antiparasitics in companion animals, drugs for reproduction, weight control, and appetite stimulation; and drugs for endocrine (e.g. thyroid, diabetes), cardiovascular (blood pressure, heart), ophthalmic, hematology, and renal/urinary disorders; as well as environmental and human food safety studies. Team 2 is led by Dr. Janet Jiang and review responsibilities include: antiparasitics in companion animals, antiparasitics for production animals (except fish), and immunosuppressants; drugs for pain, epilepsy, and for neurological, dermatological, otic, and muscular disorders. Team 3 is led by Dr. Xin Fang and covers generic drugs, antimicrobials (for respiratory [BRD, SRD] and other infections), and antivirals; drugs for cancer, pyrexia, gastrointestinal disorders (e.g., ulcers, nausea, vomiting), and respiratory (not microbial) disorders; and drugs to induce euthanasia or sedation; and production drugs and fish drugs (all indications). The goal of this session is for attendees to meet our Team members, acknowledge the organizational structure and responsibilities of CVM and the ONADE Biostatistics group, and discuss how our statisticians serve the mission of the center - Protecting Human and Animal Health.