21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products

Cite as21 CFR 201.56
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186 practice notes
  • Part II
    • United States
    • Federal Register December 10, 2007
    • December 10, 2007
    ...21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 CFR Citation: 21 CFR 201.56; 21 CFR 201.57; 21 CFR 201.80 Legal Deadline: None Abstract: To amend the regulations governing the format and content of labeling for human pr......
  • Introduction to Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions, 64075-64305 [05-21048]
    • United States
    • Federal Register October 31, 2005
    • October 31, 2005
    ...Abstract: To amend the regulations governing the format and content of labeling for human prescription drugs and biological products (21 CFR 201.56 and Statement of Need: Under FDA's current regulations, labeling concerning the use of prescription drugs in pregnancy uses letter categories (......
  • Human drugs, biological products, and animal drugs; foreign and domestic establishment registration and listing requirements,
    • United States
    • Federal Register August 29, 2006
    • August 29, 2006
    ...to define ``content of labeling'' as the content of the prescription drug labeling, as specified in Sec. Sec. 201.56, 201.57, and 201.80 (21 CFR 201.56, 201.57, and 201.80), including all text, tables, and \5\The use of the language ``that the manufacturer regards as subject to section 505 ......
  • The Regulatory Plan, 72725-72938 [06-8765]
    • United States
    • Federal Register December 11, 2006
    • December 11, 2006
    ...21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 CFR Citation: 21 CFR 201.56; 21 CFR 201.57; 21 CFR 201.80 Legal Deadline: None Abstract: To amend the regulations governing the format and content of labeling for human pr......
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79 cases
  • Finn v. G. D. Searle & Co.
    • United States
    • United States State Supreme Court (California)
    • March 29, 1984
    ...informing the medical profession of that risk. Federal law only regulates the content of labels contained in the drug package. (See 21 C.F.R. §§ 201.56, 201.57.) As the Commissioner of the Food and Drug Administration has explained, "[l]abeling is not intended to be a dispositive treatise o......
  • O'Neal v. Smithkline Beecham Corp., No. CIV S-06-1063 FCD/DAD.
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Eastern District of California
    • January 30, 2008
    ...a prescription drug is both "safe" and "effective" under the conditions of use specified in the proposed prescribing information. 21 C.F.R. §§ 201.56(d), 201.57 (FDA must be satisfied that the drug's labeling accurately describes its indications, dosages, administration, contraindications, ......
  • Pennsylvania Employees Ben. Trust v. Zeneca, No. 05-5340.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (3rd Circuit)
    • August 17, 2007
    ...either on substantial evidence or on substantial clinical experience," but the standard for labeling is substantial evidence); see 21 C.F.R. § 201.56(a)(3) (disallowing claims or suggestions of drug use on labeling if there is a lack of substantial Congress expressly gave the FDA authority ......
  • 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)
    • August 28, 2008
    ..."[t]he labeling shall contain a summary of the essential scientific information needed for the safe and effective use of the drug." 21 C.F.R. § 201.56(a).4 Drug labeling must include specific information under prescribed section headings, including, inter alia, contraindications, warnings a......
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14 firm's commentaries
  • Holding The Line On The Duty To Warn
    • United States
    • LexBlog United States
    • September 11, 2008
    ...“adulteration” and “misbranding”); 21 U.S.C. §352(a) (imposing “false or misleading in any particular” standard for misbranding); 21 C.F.R. §201.56(b) (“labeling shall be informative and accurate” and not “false or misleading in any particular”); 21 C.F.R. §201.57(f)(2) (specifying contents......
  • No Ifs, Ands Or Butts – Preemption Gutts, Rebutts, And Shutts Down Utts
    • United States
    • Mondaq United States
    • May 17, 2017
    ..."federal regulations do not require a manufacturer to include information about a competitor's product or progress." Id. at *16 (citing 21 C.F.R. §§201.56, 201.57, State-Law Warning Issues Beyond its preemption and other FDCA-related aspects, Utts II has a load of other helpful holdings, mo......
  • No Ifs, Ands Or Butts – Preemption Gutts, Rebutts, and Shutts Down Utts
    • United States
    • LexBlog United States
    • May 17, 2017
    ...“federal regulations do not require a manufacturer to include information about a competitor’s product or progress.” Id. at *16 (citing 21 C.F.R. §§201.56, 201.57, 201.80). State-Law Warning Issues Beyond its preemption and other FDCA-related aspects, Utts II has a load of other helpful hol......
  • Failure To Contraindicate Claims and Preemption
    • United States
    • LexBlog United States
    • June 26, 2017
    ...§201.57(a)(9) (emphasis added). Highlights must now be included for any prescription drug approved by the FDA after June 30, 2001. See 21 C.F.R. §201.56(c) (setting out staggered compliance schedule, completed in 2013, for drugs approved between that date and June 30, 2006, when all new dru......
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1 books & journal articles

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