21 C.F.R. § 1.3
Definitions
(a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce.
(b) Label means any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity.
Notes of Decisions
Cited in 11
cases, 1957–2013 · leading case: Robert F. Bradley v. Caspar W. Weinberger, Sec'y of Health, Educ. & Welfare, 483 F.2d 410 (1st Cir. 1973).
Robert F. Bradley v. Caspar W. Weinberger, Sec'y of Health, Educ. & Welfare, 483 F.2d 410 (1st Cir. 1973). “The motions presented for the first time the argument that the FDA’s proposed label was itself misleading and thus rendered the drug misbranded in violation of the statute, because it failed to reveal the existence of a “material weight of contrary opinion” among “experts…”
N. Trust Co. v. Upjohn Co., 572 N.E.2d 1030 (Ill. App. Ct. 1991). “” 21 C.F.R. §§1.3 (a)(1), (a)(2), 314.8(a), (b),(d),(e),(l) (1990).”
McNeil Pharm. v. Hawkins, 686 A.2d 567 (D.C. 1996). “§ 352 (a), (f), (j), and (n) ("Misbranded drugs and devices”; drug mis-branded if its labeling was found to be false or misleading); 21 C.F.R. §§ 1.3 (a)(1), (2); 314.8(a), (b), (d), (e) and (l) (labeling of drug misleading if it failed to reveal facts that were "material in…”
Mills v. Warner-Lambert Co., 581 F. Supp. 2d 772 (E.D. Tex. 2008). “21 C.F.R. § 1.3 (a); Cartwright, 369 F.Supp.”
Cartwright v. Pfizer, Inc., 369 F. Supp. 2d 876 (E.D. Tex. 2005). “21 C.F.R. § 1.3 (a). The FDA approves an NDA only if the agency “determines that the drug meets the statutory standards for safety .”
Phelps v. Wyeth, Inc., 857 F. Supp. 2d 1114 (D. Or. 2012). “” 21 C.F.R. § 1.3 (b). A label is "any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity.”
Chatman v. Pfizer, Inc., 960 F. Supp. 2d 641 (S.D. Miss. 2013). “21 C.F.R. § 1.3 defines these terms as follows: (a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce, (b) Label means any…”
SmithKline Beecham Consum. Healthcare, L.P. v. Watson Pharm., Inc., 63 F. Supp. 2d 467 (S.D.N.Y. 1999). “” 21 C.F.R. §§ 1.3 (a), 202.1(1)(2). Watson relies heavily on the fact that during the approval process for its nicotine gum, when it submitted proposed text for an audio tape substantially different from the text of the SmithKline Tape, the FDA rejected the proposed text,…”
V. E. Irons, Inc. v. United States, 244 F.2d 34 (1st Cir. 1957). “” 21 C.F.R. § 1.3 . The cases decided under the Act indicate that the jury will be allowed to determine the truth of a therapeutic claim as it would that of any other fact.”
United States of Am., Libelant-Appellee v. An Article of Device . . . Diapulse Mfg. Corp. of Am., Claimant-Appellant, 389 F.2d 612 (2d Cir. 1968). “This has been read broadly, and not improperly, in 21 C.F.R. § 1.3 : The existence of a difference of opinion, among experts qualified by scientific training and experience, as to the truth of a representation made or suggested in the labeling is a fact (among other facts) the…”
United States v. Diapulse Mfg. Corp. of Am., 269 F. Supp. 162 (D. Conn. 1967). “21 C.F.R. § 1.3 (1967) states without equivocation: “The existence of a difference of opinion, among experts qualified by scientific training and experience, as to the truth of a representation made or suggested in the labeling is a fact (among other facts) the failure to reveal…”
Annotations are extracted automatically from the opinions in the
Syfert caselaw corpus and ranked by authority, recency, and
treatment. Dots show Syfertize treatment of the citing case itself.