Regulatory framework for the availability and use of animal drugs in the United States
- PMID: 23890234
- DOI: 10.1016/j.cvsm.2013.04.001
Regulatory framework for the availability and use of animal drugs in the United States
Abstract
The goal of this article is to help practitioners understand the regulatory framework and basis for the approval of new animal drugs, the terminology and specific meaning of terms related to drug approval, and the marketing and use of veterinary drugs in companion animal practice. Understanding the differences between approved versus unapproved drugs and their use helps practitioners make the appropriate clinical decisions on their patients' treatment. Only when buying approved animal drugs can clinicians be assured of product safety, effectiveness, and manufacturing to the strict standards for quality, purity, and potency, as well as truthful and complete labeling.
Keywords: Approved versus unapproved drugs; Drug approval process; Regulatory; Safety.
Published by Elsevier Inc.
Similar articles
-
Safety surveillance in drug development: understanding the process and its implications for nephrology nursing.Nephrol Nurs J. 2002 Apr;29(2):143-50. Nephrol Nurs J. 2002. PMID: 11997949
-
Development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the US food and drug administration: the class of 2008.JAMA Intern Med. 2014 Jan;174(1):90-5. doi: 10.1001/jamainternmed.2013.11813. JAMA Intern Med. 2014. PMID: 24166236
-
Drug-review deadlines and safety problems.N Engl J Med. 2008 Mar 27;358(13):1354-61. doi: 10.1056/NEJMsa0706341. N Engl J Med. 2008. PMID: 18367738
-
How drugs are developed and approved by the FDA: current process and future directions.Am J Gastroenterol. 2014 May;109(5):620-3. doi: 10.1038/ajg.2013.407. Am J Gastroenterol. 2014. PMID: 24796999 Review.
-
Unapproved drugs in the United States and the Food and Drug Administration.Adv Ther. 2011 Oct;28(10):842-56. doi: 10.1007/s12325-011-0059-4. Epub 2011 Sep 1. Adv Ther. 2011. PMID: 21894470 Review.
Cited by
-
Species Differences in Metabolism of Soluble Epoxide Hydrolase Inhibitor, EC1728, Highlight the Importance of Clinically Relevant Screening Mechanisms in Drug Development.Molecules. 2021 Aug 19;26(16):5034. doi: 10.3390/molecules26165034. Molecules. 2021. PMID: 34443621 Free PMC article.
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Other Literature Sources