21 C.F.R. §201.128 - Meaning of "intended uses"

Cite as21 C.F.R. §201.128
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124 practice notes
49 cases
  • Knipe v. Smithkline Beecham, Civil Action No. 06-3024.
    • United States
    • United States District Courts. 3th Circuit. United States District Court (Eastern District of Pennsylvania)
    • 30 septembre 2008
    ...F.Supp.2d 553, 579-80 (E.D.Pa. Aug.28, 2008). 29. Even the FDA regulations, in theory, impose a duty to warn of off-label uses. See 21 C.F.R. § 201.128 ("if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug introduced into interstate commerce by him is ......
  • Baker v. Johnson
    • United States
    • United States District Courts. 7th Circuit. Southern District of Illinois
    • 26 mai 2010
    ...contend that because the complaint contains a count alleging negligence per se on the basis of an alleged violation by Defendants of 21 C.F.R. § 201.128, the negligence per se count constitutes a separate and independent claim arising under federal law within the meaning of 28 U.S.C. § 1441......
  • US v. Kasz Enterprises, Inc., Civ. A. No. 93-0455 P.
    • United States
    • United States District Courts. 1st Circuit. United States District Courts. 1st Circuit. District of Rhode Island
    • 15 juin 1994
    ...The intended use of a product is determined by the vendor's objective intent in promoting, distributing, and selling the product. See 21 C.F.R. § 201.128; Sudden Change, 409 F.2d at 739. Objective intent can be demonstrated by, among other things, "labeling" claims, advertising material, or......
  • Coyne Beahm, Inc. v. U.S. Food & Drug Admin., 2:95CV00591.
    • United States
    • United States District Courts. 4th Circuit. Middle District of North Carolina
    • 25 avril 1997
    ...Finally, Plaintiffs argue that FDA's own regulations require evidence of manufacturer representations to establish intended use. See 21 C.F.R. §§ 201.128, 801.4 (defining "intended use" regarding drugs and devices, respectively).15 Although the regulations defining "intended use" clearly an......
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65 firm's commentaries
  • Off-Label Use – The Times They Are A Changin’
    • United States
    • LexBlog United States
    • 8 octobre 2009
    ...from “express[ing]” an “intent” or merely “know[ing]” or having “notice” that its product “is to be used” off-label. 21 C.F.R. §§201.100, 201.128; see 21 U.S.C. §352(f)(1). Preliminary Injunction Motion at 2-3. Each step, the motion charges, is unconstitutional because there is no clear int......
  • Business Litigation Report -- April 2013
    • United States
    • JD Supra United States
    • 15 avril 2013
    ...Caronia’s alleged off-label promotional activities were unlawful based on Sections 331(a) and 352(f) of the FDCA and 21 C.F.R. §§ 201.5 and 201.128. The government argued that these sections, when read together, provide that a drug is misbranded if it is introduced into interstate commerce ......
  • Caronia, The Latest
    • United States
    • JD Supra United States
    • 1 septembre 2011
    ...use.” U.S. br. at 6. That’s a distinction without a difference. An ancient FDA regulation (substantively unchanged since the 1950s), 21 C.F.R. §201.128, equates one with the other. Promoting (truthfully or otherwise) off-label automatically changes the “intended use,” and the new “intended ......
  • The First Amendment and Off-Label Promotion: United States v. Caronia
    • United States
    • JD Supra United States
    • 11 avril 2013
    ...Caronia’s alleged off-label promotional activities were unlawful based on Sections 331(a) and 352(f) of the FDCA and 21 C.F.R. §§ 201.5 and 201.128. The government argued that these sections, when read together, provide that a drug is misbranded if it is introduced into interstate commerce ......
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