FDA对实验室开发测试的建议指南:监管机构应如何平衡临床遗传学创新的风险和前景?

{"title":"FDA对实验室开发测试的建议指南:监管机构应如何平衡临床遗传学创新的风险和前景?","authors":"Michelle Bayefsky, Benjamin E Berkman","doi":"","DOIUrl":null,"url":null,"abstract":"","PeriodicalId":91078,"journal":{"name":"FDLI's food and drug policy forum","volume":"5 2","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2015-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4593508/pdf/nihms685202.pdf","citationCount":"0","resultStr":"{\"title\":\"FDA's Proposed Guidance for Laboratory Developed Tests: How Should Regulators Balance the Risks and Promise of Innovation in Clinical Genetics?\",\"authors\":\"Michelle Bayefsky, Benjamin E Berkman\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"\",\"PeriodicalId\":91078,\"journal\":{\"name\":\"FDLI's food and drug policy forum\",\"volume\":\"5 2\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2015-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4593508/pdf/nihms685202.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"FDLI's food and drug policy forum\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2015/2/25 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"FDLI's food and drug policy forum","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2015/2/25 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}