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- W9363439 abstract "The Food & Drug Administration (FDA) published, on June 26, 1979, a regulation, “Labeling for Prescription Drugs Used in Man ”. This rule for the package insert or professional labeling describes in detail the information required in the insert and even suggests how it may be said. The changes corect the tendency on the part of some manufacturers to describe to practitioners the merits of the drug without giving information regarding its hazards and special precautions necessary for maximum safety and effectiveness. The regulation directs the use of explicit information on indications and the replacement of generalities with specifics. In effect, all labeling will be brought to a uniform level — that of the best product monographs written. The section on Clinical Pharmacology will now include specific biopharmaceutics data on the drug(s), specific pharmacokinetics and any other information which is pertinent to the drug's clinical use. The section on Precautions is now made up of nine subsections — one section, pregnancy, will identify a category (A, B, C, D or X) that applies to the drug. The categories will tell the practitioner the potential risk for the fetus and a progressive degree of caution that should be exercised accordingly in the various categories. For Adverse Reactions, incidence and severity data will be provided for the practitioner. Other information about the drug product is provided in separate sections to inform the prescriber on the safest and most effective use of the drug." @default.
- W9363439 created "2016-06-24" @default.
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- W9363439 date "1982-01-01" @default.
- W9363439 modified "2023-09-27" @default.
- W9363439 title "The Physician's Labeling — An American Point of View" @default.
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- W9363439 doi "https://doi.org/10.1016/b978-0-08-027074-6.50032-2" @default.
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