title: Translating research into licensed vaccines and validated and licensed diagnostic tests.
abstract: The USDA Center for Veterinary Biologics (CVB) has the regulatory authority to issue licenses and permits that allow the marketing of pure, safe, potent, and effective veterinary biological products. Under the standard licensing or permitting process, a manufacturer develops, characterizes, and evaluates a product prior to licensure. The CVB evaluates the submitted information, inspects the manufacturing facilities and methods of production and testing, and confirms key product test results through independent testing. This complete and comprehensive evaluation may not be possible during the emergence of a new animal disease or in response to an introduction of a significant transboundary animal disease agent. Processes are in place in the US that allow for more rapid availability of veterinary products in an emerging or emergency animal health situation. But, it can be advantageous to attain preapproval of products prior to their anticipated need. In this article, issues associated with obtaining approval for use of a biological product under emerging or emergency conditions are discussed.
authors.affiliation: USDA, Animal and Plant Health Inspection Service, Veterinary Services, Center for Veterinary Biologics, Ames, IA, USA.
authors.forename: R E
authors.initials: RE
authors.lastname: Hill
authors.forename: P L
authors.initials: PL
authors.lastname: Foley
authors.forename: N E
authors.initials: NE
authors.lastname: Clough
authors.forename: L R
authors.initials: LR
authors.lastname: Ludemann
authors.forename: D C
authors.initials: DC
authors.lastname: Murtle
mesh_terms: D000818:Animals; D021821:Communicable Diseases, Emerging; D003955:Diagnostic Tests, Routine / Q000379:methods / Q000662:veterinary*; D007886:Legislation, Veterinary; D012106:Research; D018581:Technology Transfer; D014481:United States; D016885:United States Department of Agriculture; D014486:United States Food and Drug Administration; D014612:Vaccines / Q000276:immunology*
chemical_list: D014612:Vaccines