Show simple item record

dc.contributor.editorLienhard, Dina A.en_US
dc.creatorMeek, Caroline
dc.date2019-10-31en_US
dc.date.accessioned2019-10-31T19:57:30Z
dc.date.available2019-10-31T19:57:30Z
dc.date.created2019-10-31
dc.identifier.urihttps://hpsrepository.asu.edu/handle/10776/13131
dc.description.abstractThe United States Food and Drug Administration, or FDA, published 'General Considerations for the Clinical Evaluation of Drugs,' in September 1977. The document defined acceptable practices for investigators who studied new drugs. Specifically, the document outlined the common clinical trial methods. Clinical trials are studies to test whether a new drug is safe before doctors can prescribe it to patients. Prior to 1977, the Protection of Human Subjects Rule primarily regulated clinical drug trials, but it did not specify who could and could not be included in clinical trials. In the document, the FDA recommended that anyone who could become pregnant be excluded from early-phase clinical trials to minimize risks to a potential fetus. After the FDA published the document, investigators excluded women from clinical trials. The document ultimately prevented women of reproductive capacity from participating in early phase clinical trials, which affected women’s health research.en_US
dc.format.mediumtext/xhtmlen_US
dc.language.isoen_USen_US
dc.language.isoen_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.subjectLiteratureen_US
dc.subject.lcshUnited States. Food and Drug Administrationen_US
dc.subject.lcshFDAen_US
dc.subject.lcshClinical trialsen_US
dc.subject.lcshDrugsen_US
dc.subject.lcshMedicationsen_US
dc.subject.lcshPharmaceuticalsen_US
dc.subject.meshPharmaceutical Preparationsen_US
dc.title“General Considerations for the Clinical Evaluation of Drugs” (1977), 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.subject.embryoPublicationsen_US
dc.subject.tagGeneral Considerationsen_US
dc.subject.tagFDAen_US
dc.subject.tagClinical trialen_US
dc.subject.tagDrugs, medicinesen_US
dc.description.typeArticlesen_US


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record