0161 Embracing innovation in the animal drug approval process. (1st October 2016)

• Record Type: Journal Article
• Authors: Sholly, D. M.; Taylor-Edwards, C.
• Is Part Of: Journal of animal science. Volume 94(2016)Supplement 5
• Page Start: 78
• Page End: 78
• Publication Date: 2016-10-01
• Subjects: animal health -- drug -- FDA -- food -- innovation -- livestock; Livestock -- Periodicals; Livestock; Electronic journals; Periodicals; 636.005
• DOI: 10.2527/jam2016-0161
• Languages: English
• ISSNs: 0021-8812

Abstract

Abstract: The mission of the Center for Veterinary Medicine (CVM) in the U.S. Food and Drug Administration (FDA) is to protect human and animal health. CVM's Office of New Animal Drug Evaluation encourages the development of new innovative technologies and non-traditional therapeutic indications as one means of facilitating this mission and to meet the growing needs in the animal care and food and fiber production sectors. CVM is committed to maximizing use of all forms of available information to meet this challenge. Current tools being implemented and/or investigated include use of scientific focus groups/technology teams, evaluation of "Early Information, " pre-development meetings with drug sponsors, and CVM Outreach to academic bench scientists through, webinars and industry meeting presentations. These tools allow CVM to gather information, identify data gaps, and implement benefit-risk analysis decisions early in the drug approval process. Drug application review also affords the opportunity for continued communication between CVM, research scientists, and sponsors, as well as providing a channel for end-user feedback to CVM. Additional tools include expanded use of literature to support data requirements, use of electronic data capture, systematic reviews and meta-analyses, and collaborative data sharing within CVM and across international regulatory groups. Many of these new tools and approaches rely heavily on the academic research community through consultations, published peer-reviewed information, and as study investigators. Scientists should consider and identify the applicability of their research and, just as importantly, foster productive partnerships with drug sponsors. An understanding of the regulatory processes underlying animal drug development and the tools used by CVM to evaluate data to support drug development is critical to the growth of the animal drug industry and the animal sciences industries. The benefit of innovative approaches to drug sponsors includes but is not limited to early and continual feedback from CVM, increased predictability of drug development requirements, and consistent application of requirements leading to global approval and use of an animal drug. The benefit to the researcher is continued partnerships with the animal drug industry and increased communication on how their scientific program could support drug development. The benefit to the public is increased availability of safe and effective drugs for use in production animals.