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dc.contributor.editorDhein, Kelleen_US
dc.creatorMeek, Caroline
dc.date.accessioned2019-01-28T21:14:04Z
dc.date.available2019-01-28T21:14:04Z
dc.date.created2019-01-28
dc.identifier.urihttps://hpsrepository.asu.edu/handle/10776/13089
dc.description.abstractThe US Food and Drug Administration, or FDA, published the “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs,” henceforth “Study of Gender Differences,” in July 1993. The document defined acceptable practices for investigators studying new drugs. Prior to 1993, investigators excluded most women from clinical trials because in 1977, the FDA recommended that anyone who could possibly become pregnant be excluded from early phase drug research to minimize risk to a potential fetus. In 1997, the FDA reversed that guidance, advising investigators to include women in early phase drug research, a decision that reflected changing views about a woman’s ability to decide whether to participate in drug trials and furthering research on the effects of drugs on women.en_US
dc.format.mediumtext/xhtmlen_US
dc.language.isoen_USen_US
dc.language.isoen_USen_US
dc.publisherArizona State University. School of Life Sciences. Center for Biology and Society. Embryo Project Encyclopedia.en_US
dc.rightsCopyright Arizona Board of Regentsen_US
dc.subjectLawen_US
dc.subject.lcshUnited States. Food and Drug Administrationen_US
dc.subject.lcshDrug Approvalen_US
dc.subject.lcshWomen's health services--United Statesen_US
dc.subject.lcshLegislation, Drugen_US
dc.subject.lcshUnited States. National Institutes of Health Revitalization Act of 1993en_US
dc.subject.lcshClinical medicine--Researchen_US
dc.subject.lcshMedical research personnelen_US
dc.subject.lcshNational Institutes of Health (U.S.). Office of Extramural Researchen_US
dc.subject.lcshNational Institutes of Health (U.S.). Office for Protection from Research Risksen_US
dc.subject.lcshClinical trials--United Statesen_US
dc.subject.lcshClinical trials--Law and legislationen_US
dc.subject.lcshDrugs--Testingen_US
dc.subject.lcshClinical Trial Servicesen_US
dc.subject.meshGenderen_US
dc.subject.meshClinical Trialen_US
dc.title“Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs” (July 1993), by the United States Food and Drug Administrationen_US
dc.typeArticleen_US
dc.typeTexten_US
dc.rights.licenseLicensed as Creative Commons Attribution-NonCommercial-Share Alike 3.0 Unported (CC BY-NC-SA 3.0) http://creativecommons.org/licenses/by-nc-sa/3.0/en_US
dc.rights.licenseEmbryo Project Encyclopediaen_US
dc.subject.embryoPublicationsen_US
dc.subject.tagClinical Researchen_US
dc.subject.tagClinical Researchen_US
dc.subject.tagwomen's healthen_US
dc.subject.tagUS Food and Drug Administrationen_US
dc.description.typeArticlesen_US


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