21 CFR 201.57 - Specific requirements on content and format of labeling for human prescription drug and biological products described in section 201.56(b)(1)
| Cite as | 21 CFR 201.57 |
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377 practice notes
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Part II
...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 prescription dr......
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Introduction to Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions, 64075-64305 [05-21048]
...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 201.57 Legal To amend the regulations governing the format and content of labeling for human prescription drugs and biological products (21 CFR 201.56......
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Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions-Fall 2017
...seq.; 42 U.S.C. 262; 42 U.S.C. 264; 21 U.S.C. 371 CFR Citation: 21 CFR 208; 21 CFR 606.123 (new); 21 CFR 310.501 and 310.515 (removal); 21 CFR 201.57 (a)(18) (revision); 21 CFR 201.809(f)(2) (revision); 21 CFR 314.70(b)(2)(v)(B) (revision); 21 CFR 610.60(a)(7) (removal); . . Legal Deadline:......
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The Regulatory Plan, 72725-72938 [06-8765]
...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 prescription dr......
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250 cases
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Wyeth v. Sandoz Inc, No. 5:07-CV-234-D.
...'958 patent (claims 4, 6). 6. “Tmax” is the time after administration of a drug when the maximum plasma concentration is reached. See 21 C.F.R. § 201.57(c)(13)(C). 7. Aventis Pharma Deutschland GmbH v. Cobalt Pharm., Inc., 355 F.Supp.2d 586 (D.Mass.2005); Organon, Inc. v. Teva Pharm., Inc.,......
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Carlin v. Superior Court, No. S045912
...of adverse reactions when differences of opinion exist within the medical community with regard to potential adverse reactions. (See 21 C.F.R. § 201.57(d) & (e) (1996) [requiring that warnings shall only be of known hazards, not theoretical hazards]; id., § 1.21(c)(1) [prohibiting the inclu......
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Finn v. G. D. Searle & Co.
...of case under a duty to warn rationale. Since the warnings which drug manufacturers provide are strictly regulated by federal law (see 21 C.F.R. § 201.57, subds. (d), (e), (g)), it would be illegal and a violation of public policy for the manufacturer to warn about adverse reactions and con......
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O'Neal v. Smithkline Beecham Corp., No. CIV S-06-1063 FCD/DAD.
...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, warnings and pr......
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57 firm's commentaries
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Daubert Decision in Baycol Raises Interesting Legal Points
...claims concerning regulated products unless supported the manufacturer can back them up with “adequate and well controlled studies.” 21 C.F.R. §201.57(c)(3)(v); see 44 Fed. Reg. 37434, 37441 (item 35), 37446 (item 58) (FDA June 28, 1979) (discussing this requirement). Well, that’s not what ......
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What If We Win? Off-Label Promotion & Product Liability
...itself remains off-label. The FDA, however, can order a drug’s label to contain statements (usually warnings) about an off-label use. 21 C.F.R. §§201.57(c)(6)(i), 201.80(e) (both phrased in terms of “required by” the FDA). That’s important because, as we discussed in more detail here, only ......
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What If We Win? Off-Label Promotion & Product Liability
...itself remains off-label. The FDA, however, can order a drug's label to contain statements (usually warnings) about an off-label use. 21 C.F.R. §§201.57(c)(6)(i), 201.80(e) (both phrased in terms of "required by" the FDA). That's important because, as we discussed in more detail here, only ......
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“A Causal Relationship Need Not Have Been Proved”
...as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established.” 21 C.F.R. §201.57(c)(6)(i). For drugs approved before then, the FDA’s administrative standard demands that drug warnings be revised “as soon as there is rea......
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4 books & journal articles
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Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety
...AND PROTECTING THE HEALTH OF THE PUBLIC 17 (2007), available at http://books.nap.edu/ openbook.php?record_id=11750&page=R1. 37. 21 C.F.R. § 201.57(c)(6)(i). 38 . CTR. FOR DRUG EVALUATION & RESEARCH & CTR. FOR BIOLOGICS EVALUATION & RESEARCH, FDA, U.S. DEP’T OF HEALTH & HUMAN SERVS., GUIDANC......
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The More Things Change: Improvement Patents, Drug Modifications, and the FDA
...The Limited Case for Penalizing Failures to Innovate , 82 U. CHI. L. REV. 1781, 1789–811 (2015). 84 . See infra Section V.B. 85 . See 21 C.F.R. § 201.57 (2018); Labeling Information for Drug Products , U.S. FOOD & DRUG ADMIN., https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Development......
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Save Now, Pay Later: The Unfortunate Reality of PLIVA v. Mensing
...Clause “any [state law] to the Contrary notwithstanding,” is a non obstante provision. 136 This provision, 126. Id. (quoting 21 C.F.R. § 201.57(e) (2006)) (internal quotation marks omitted). 127. Id. 128. Id. at 2576–77. 129. Id. at 2576. Such help by the FDA would require the brand name to......
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Nonprice Competition in “Substitute” Drugs: The FTC's Blind Spot
...ne Fo x, Th e Hid de n Rol e of Co st : Med ica re De cis io ns,Transparencyand Public Trust, 79 U. CIN. L. REV. 1, 17 (2010).25See 21 C.F.R. § 201.57(c)(6)(i).26 See 21 U.S.C. § 551(b)(1)(A); Applications for FDAApproval to Marketa New Drug, 21 C.F.R. § 314.70(a) (2014).27 Prescription Dru......
3 provisions
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File 155, SB 229 – Modify Board of Pharmacy and controlled substances laws
...(d) Any other information in the patient counseling information section of the labeling for the opioid analgesic required under 21 C.F.R. 201.57(c)(18). (3) Obtain written consent for the prescription from the minor's parent, guardian, or, subject to division (E) of this section, another ad......
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Act 112, SB 572 – Health and Safety (35 Pa.C.S.) - opioid treatment agreements (effective IMMEDIATELY)
...benzodiazepines, alcohol or other central nervous system depressants. (iv) Other information deemed appropriate by the prescriber under 21 CFR 201.57(c)(18) (relating to specific requirements on content and format of labeling for human prescription drug and biological products described in ......
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Act 23, AB 125 – Relating to: regulation of physician assistants, creating a Physician Assistant Affiliated Credentialing Board, extending the time limit for emergency rule procedures, providing an exemption from emergency rule procedures, granting rule-making authority, and providing a penalty. (FE)
...home resident who has degenerative brain disorder shall notify the nursing home if the prescribed medication has a boxed warning under 21 CFR 201.57. SECTION 12. 50.39 (3) of the statutes is amended to 50.39 (3) Facilities governed by ss. 45.50, 48.62, 49.70, 49.72, 50.02, 51.09, and 252.10......