 | 2003 - 210 pages
...§314.126(b) of this chapter. (d) Contraindications. Under this section heading, the labeling shall describe those situations in which the drug should not be used...risk of use clearly outweighs any possible benefit. These situations include administration of the drug to patients known to have a hypersensitivity to... | |
 | United States. General Accounting Office - 1980 - 104 pages
...specific with regard to identification of contraindicated drugs. FDA defines contraindications to be "* * *those situations in which the drug should not be...risk of use clearly outweighs any possible benefit." Our Chief Medical Advisor identified 13 cases of contraindicated drugs among the 212 patients (6.1... | |
 | International Validation Forum - 1995 - 1114 pages
...the safe and effective use of a device, o Contraindications describe situations in which the device should not be used because the risk of use clearly outweighs any reasonably foreseeable benefits. device when found in the labeling, promotional materials, advertising... | |
 | International Validation Forum - 1996 - 860 pages
...the safe and effective use of a device. ° Contraindications describe situations in which the device should not be used because the risk of use clearly outweighs any reasonably foreseeable benefits.16 4. Documentation: Recording the results of applying the model to... | |
 | United States. Congress. Senate. Committee on Labor and Human Resources - 1998 - 236 pages
...201.57(d) states: "Contraindications" — "Under this section heading, the labeling shall describe those situations in which the drug should not be used...risk of use clearly outweighs any possible benefit. Subsection (e) "Warnings" states: Under this section heading, the labeling shall describe serious adverse... | |
 | Rick Ng - 2005 - 368 pages
...drug in the treatment, prevention or diagnosis of a recognized disease or condition. Description of situations in which the drug should not be used because...risk of use clearly outweighs any possible benefit. Description of serious adverse reactions and potential safety hazards, subsequent limitation in use,... | |
 | James Beck, Anthony Vale - 2004 - 982 pages
...clinical data. 21 CFR § 210.57(c)(3)(v). 27 21 CFR § 210.57(d). A contraindication is a "situation!] in which the drug should not be used because the risk of use clearly outweighs any possible benefit." lit. Only known hazards and not theoretical possibilities are to be listed. Id. 28 21 CFR § 210.57(e).... | |
 | Hugh B. Wellons - 2007 - 1016 pages
...treatment, prevention or diagnosis of a recognized disease or condition. Contraindications Description of situations in which the drug should not be used because...risk of use clearly outweighs any possible benefit. Warnings Description of serious adverse reactions and potential safety hazards, subsequent limitation... | |
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Contraindications. Under this section heading, the labeling shall describe those situations in which the drug should not be used because the risk of use clearly outweighs any possible benefit. 
