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Off-label (view source)

Revision as of 00:51, September 26, 2022

819 bytes added ,  00:51, September 26, 2022
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''Blazoski v. Cook'', 346 N.J. Super. 256, 272, 787 A.2d 910, 919-20 (Super. Ct. App. Div. 2002)
 
''Blazoski v. Cook'', 346 N.J. Super. 256, 272, 787 A.2d 910, 919-20 (Super. Ct. App. Div. 2002)
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<blockquote>However, physicians may exercise their independent medical judgment to prescribe FDA-approved drugs to treat conditions other than those for which the drug is approved, if appropriate for the particular patient.25
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Absent state regulation, once a drug has been approved by FDA, doctors may prescribe it for indications and in dosages other than those expressly approved by the FDA. This is a widely employed practice known as "off-label" use. Off-label use does not violate federal law or FDA regulations because the FDA regulates the marketing and distributing of drugs in the United States, not the practice of medicine, which is the exclusive realm of the individual states.</blockquote>
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''Goico v. United States FDA'', No. 20-1248-JAR-KGG, 2020 U.S. Dist. LEXIS 226868, at *8-9 (D. Kan. Dec. 3, 2020).
 
<blockquote>(not a quote) lack of FDA approval does not prohibit a physician from "off label" use</blockquote>
 
<blockquote>(not a quote) lack of FDA approval does not prohibit a physician from "off label" use</blockquote>
 
Kirkman v. Sofamor, S.N.C., 1998 U.S. Dist. LEXIS 13357, 1998 WL 666706 at *4 (W.D. N.C. July 21, 1998)
 
Kirkman v. Sofamor, S.N.C., 1998 U.S. Dist. LEXIS 13357, 1998 WL 666706 at *4 (W.D. N.C. July 21, 1998)
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