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Medical Product Label
Definition 1
Any display of a written, printed, or graphic matter upon the immediate container of any substance or device to identify something and to indicate the nature, ownership, contents and other characteristic particulars of the object. FDA and the Supreme Court have stated that label is to be interpreted liberally, and includes not only that which accompanies an article but also that which spiritually accompanies an article as well as supplements. Drug label must include: trademark and category of product, description of product chemical and physical characteristics, clinical pharmacology, pharmacokinetics, data on absorption, distribution, metabolism and excretion, special populations, clinical studies, efficacy and safety data, indications, contraindications, adverse events warnings and precautions including lab tests; potential drug interactions, carcinogens statement, pregnancy category. (NCI Thesaurus)
Definition 2
Description of a drug product/device that includes: the indication, who should use it, adverse events, instructions for use, and safety information. NOTE: Labels must be approved by regulatory authorities [FDA; SPL] (NCI Thesaurus/CDISC)
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