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dc.contributor.editorLaTourelle, Jonathan J.en_US
dc.creatorTantibanchachai, Chanapaen_US
dc.date.accessioned2014-04-01T18:06:40Z
dc.date.available2014-04-01T18:06:40Z
dc.date.created2014-04-01en_US
dc.date.issued2014-04-01
dc.identifier.urihttp://hdl.handle.net/10776/7733
dc.description.abstractThalidomide, a drug capable of causing fetal abnormalities (teratogen), has caused greater than ten thousand birth defects worldwide since its introduction to the market as a pharmaceutical agent. Prior to discovering thalidomide's teratogenic effects in the early 1960s, the US Food and Drug Administration (FDA) did not place regulations on drug approval or monitoring as it later did. By 1962, approximately 20,000 patients in the US had taken thalidomide as part of an unregulated clinical trial before any actions were taken to stop thalidomide's distribution. Due to thalidomide's effects on fetuses, both nationally and abroad, the US Congress passed the 1962 Kefauver-Harris Amendments to the 1938 Food, Drug, and Cosmetic Act. These amendments imposed guidelines for the process of drug approval in the US and required that a drug be safe as well as effective before it could be approved and marketed. Thalidomide also influenced the FDA's creation of pregnancy categories; a ranking of drugs based on their effects on reproduction and pregnancy. Thalidomide motivated the laws on regulating and monitoring drugs developed in the US and by the FDA in the twentieth and twenty-first centuries.en_US
dc.format.mediumtext/xhtmlen_US
dc.language.isoengen_US
dc.publisherArizona State University. School of Life Sciences. Center for Biology and Society. Embryo Project Encyclopedia.en_US
dc.relation.ispartofEmbryo Project Encyclopediaen_US
dc.rightsCopyright Arizona Board of Regentsen_US
dc.subjectContexten_US
dc.subject.lcshThalidomideen_US
dc.subject.lcshThalidomide--Side effectsen_US
dc.subject.lcshTeratogenicity testingen_US
dc.subject.lcshUnited States. Food and Drug Administrationen_US
dc.subject.lcshLenz, Widukinden_US
dc.subject.lcshKefauver, Estes, 1903-1963en_US
dc.subject.meshMultiple Myelomaen_US
dc.subject.meshHIVen_US
dc.subject.meshLeprosyen_US
dc.titleUS Regulatory Response to Thalidomide (1950-2000)en_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.subject.embryoLegalen_US
dc.subject.embryoReproductionen_US
dc.description.typeArticlesen_US


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