title: Overview of the animal health drug development and registration process: an industry perspective.
abstract: Products for animal health commercialization follow a structured progression from initial concept through to regulatory approval. Typically, products are developed for use in either food animals or companion animals. These can be for the intention of disease intervention, productivity enhancement or improvement in a quality of life capacity. The animal health industry is a regulated industry, meaning that a government agency is responsible for oversight of products, both pre- and post-approval. There are three primary US government agencies that ensure quality, safety and effectiveness for the approval of new products and post-marketing compliance.
authors.affiliation: Elanco Animal Health, Division of Eli Lilly & Co., 2500 Innovation Way, Greenfield, IN 46140, USA. hunterrp@lilly.com
authors.forename: Robert P
authors.initials: RP
authors.lastname: Hunter
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Shryock
authors.forename: Brian R
authors.initials: BR
authors.lastname: Cox
authors.forename: Roger M
authors.initials: RM
authors.lastname: Butler
authors.forename: Jason E
authors.initials: JE
authors.lastname: Hammelman
mesh_terms: D000827:Animal Welfare / Q000191:economics; D000818:Animals; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry; D033161:Government Regulation; D019155:Veterinary Drugs / Q000494:pharmacology*
chemical_list: D019155:Veterinary Drugs