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J. Halpern, B. Chughtai, H. Ghomrawi (2017)
Cost-effectiveness of Common Diagnostic Approaches for Evaluation of Asymptomatic Microscopic HematuriaJAMA Internal Medicine, 177
L. Subak, D. Grady (2017)
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Letters 7. Fadiran EO, Zhang L. Effects of Sex Differences in the Pharmacokinetics of fulfill different purposes, which may lead to differences in the Drugs and Their Impact on the Safety of Medicines in Women. In: number of sex-specific statements. Harrison-Woolrych M, ed. Medicines For Women. Cham: Springer International The label is a regulatory document meant to provide a sum- Publishing; 2015:41-68. mary of the scientific information needed for the safe and ef- fective use of the drug. The drug label cannot contain effi- cacy claims for subpopulations if the evidence for such claims does not meet the “substantial evidence” standard. Unlike the To the Editor An Original Investigation by Halpern and 1 2 required subsections for geriatric and pediatric age (sections colleagues and Invited Commentary by Subak and Grady, both 8.4 and 8.5), which must be included in labeling regardless published in a recent issue of JAMA Internal Medicine, sug- of whether there is informative data, sex demographic infor- gest that evaluation of asymptomatic microscopic hematuria mation is not a required subsection. What data on sex-based may not be cost-effective. Their focus was on subsequent rec- differences to include is determined during the review pro- ognition of genitourinary
JAMA Internal Medicine – American Medical Association
Published: Dec 1, 2017
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