title: The regulation of veterinary regenerative medicine and the potential impact of such regulation on clinicians and firms commercializing these treatments.
abstract: This article provides an overview of the US Food and Drug Administration's current and potential regulation of veterinary regenerative medicine and the various products used in the practice. This article also discusses several of the potential enforcement risks associated with the commercialization of such therapies and products and offers the reader strategies for mitigating those risks. Finally, the article concludes with a review of an important and ongoing court battle that focuses on the marketing and promotion of cellular-based therapies for humans that could have a significant impact on the regulation of both human and veterinary products.
authors.affiliation: K&L Gates LLP, 1601 K Street, NW, Washington, DC 20006, USA. karl.nobert@klgates.com
authors.forename: Karl M
authors.initials: KM
authors.lastname: Nobert
mesh_terms: D000329:Advertising / Q000331:legislation & jurisprudence / Q000592:standards; D000818:Animals; D006801:Humans; D007886:Legislation, Veterinary / Q000592:standards*; D044968:Regenerative Medicine / Q000592:standards*; D012307:Risk Factors; D012958:Societies, Scientific; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence; D014730:Veterinary Medicine / Q000592:standards* / Q000639:trends