An animal drug (also veterinary drug) refers to a drug intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals.
The U.S. Food and Drug Administration (FDA) has the broad mandate under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) to assure the safety and effectiveness of animal drugs and their use in all animals, including farm animals. The division of the FDA responsible for this is the Center for Veterinary Medicine (CVM).[1] The equivalents of the Investigational New Drug and New Drug Application are known as the Investigational New Animal Drug and New Animal Drug Application, respectively. The FDA enumerates veterinary drug approvals in the FDA Green Book. Drugs approved by the FDA for use in veterinary medicine are structurally similar to drugs approved for use in humans, owing to highly conserved physiology across species, and half of drugs approved for animals are separately approved for use in humans.[1][2]
Before CVM formally approves an animal drug, the sponsor or manufacturer of the drug must document in scientific testing that the drug has been found "safe and effective". The testing data also must demonstrate that a methodology is available to detect and measure any residue left in edible animal products. Farmers and veterinarians using drugs on farm animals must adhere to guidelines about how much time must elapse before a treated animal can be slaughtered, and any other use constraints or warnings stated on the drug label.
^Post, Lynn O (2007). "Chapter 7: Regulatory considerations in veterinary toxicology". In Gupta, RC (ed.). Veterinary toxicology basic and clinical principles (1st, revised ed.). New York: Academic Press. pp. 92–109. ISBN9780080481609.
^Scott, Kevin A.; Qureshi, M. Haziq; Cox, Philip B.; Marshall, Christopher M.; Bellaire, Bailey C.; Wilcox, Michael; Stuart, Bradey A. R.; Njardarson, Jon T. (2020-12-24). "A Structural Analysis of the FDA Green Book-Approved Veterinary Drugs and Roles in Human Medicine". Journal of Medicinal Chemistry. 63 (24): 15449–15482. doi:10.1021/acs.jmedchem.0c01502. ISSN 0022-2623. PMID 33125236. S2CID 226218045.
animal, drug, examples, perspective, this, article, represent, worldwide, view, subject, improve, this, article, discuss, issue, talk, page, create, article, appropriate, april, 2011, learn, when, remove, this, template, message, animal, drug, also, veterinary. The examples and perspective in this article may not represent a worldwide view of the subject You may improve this article discuss the issue on the talk page or create a new article as appropriate April 2011 Learn how and when to remove this template message An animal drug also veterinary drug refers to a drug intended for use in the diagnosis cure mitigation treatment or prevention of disease in animals Contents 1 Regulation 1 1 United States 2 See also 3 References 4 External linksRegulation editUnited States edit The U S Food and Drug Administration FDA has the broad mandate under the Federal Food Drug and Cosmetic Act 21 U S C 321 et seq to assure the safety and effectiveness of animal drugs and their use in all animals including farm animals The division of the FDA responsible for this is the Center for Veterinary Medicine CVM 1 The equivalents of the Investigational New Drug and New Drug Application are known as the Investigational New Animal Drug and New Animal Drug Application respectively The FDA enumerates veterinary drug approvals in the FDA Green Book Drugs approved by the FDA for use in veterinary medicine are structurally similar to drugs approved for use in humans owing to highly conserved physiology across species and half of drugs approved for animals are separately approved for use in humans 1 2 Before CVM formally approves an animal drug the sponsor or manufacturer of the drug must document in scientific testing that the drug has been found safe and effective The testing data also must demonstrate that a methodology is available to detect and measure any residue left in edible animal products Farmers and veterinarians using drugs on farm animals must adhere to guidelines about how much time must elapse before a treated animal can be slaughtered and any other use constraints or warnings stated on the drug label Animal biologics e g vaccines and tests are regulated by the Animal and Plant Health Inspection Service See also editDrug packaging List of veterinary drugs Veterinary medicine Veterinary pathologyReferences edit Post Lynn O 2007 Chapter 7 Regulatory considerations in veterinary toxicology In Gupta RC ed Veterinary toxicology basic and clinical principles 1st revised ed New York Academic Press pp 92 109 ISBN 9780080481609 Scott Kevin A Qureshi M Haziq Cox Philip B Marshall Christopher M Bellaire Bailey C Wilcox Michael Stuart Bradey A R Njardarson Jon T 2020 12 24 A Structural Analysis of the FDA Green Book Approved Veterinary Drugs and Roles in Human Medicine Journal of Medicinal Chemistry 63 24 15449 15482 doi 10 1021 acs jmedchem 0c01502 ISSN 0022 2623 PMID 33125236 S2CID 226218045 nbsp This article incorporates public domain material from Jasper Womach Report for Congress Agriculture A Glossary of Terms Programs and Laws 2005 Edition PDF Congressional Research Service External links editApproved Animal Drugs at FDA website Animal drugs at DailyMed website Retrieved from https en wikipedia org w index php title Animal drug amp oldid 1171265456, wikipedia, wiki, book, books, library,
