{"title":"FDA,戈特利布,面对真实世界的证据。","authors":"Richard Mark Kirkner","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>Here we are in early 2019, and how quickly and firmly the FDA and the pharmaceutical industry will embrace RWE and its raw material, real-world data (RWD), remains an open question. If that embrace is ever to get beyond gestures and lip service, the FDA will need to change its rules and culture.</p>","PeriodicalId":39329,"journal":{"name":"Managed Care","volume":"28 3","pages":"13-16"},"PeriodicalIF":0.0000,"publicationDate":"2019-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"FDA, Gottlieb Get Real About Real-world evidence.\",\"authors\":\"Richard Mark Kirkner\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Here we are in early 2019, and how quickly and firmly the FDA and the pharmaceutical industry will embrace RWE and its raw material, real-world data (RWD), remains an open question. If that embrace is ever to get beyond gestures and lip service, the FDA will need to change its rules and culture.</p>\",\"PeriodicalId\":39329,\"journal\":{\"name\":\"Managed Care\",\"volume\":\"28 3\",\"pages\":\"13-16\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2019-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Managed Care\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Managed Care","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
Here we are in early 2019, and how quickly and firmly the FDA and the pharmaceutical industry will embrace RWE and its raw material, real-world data (RWD), remains an open question. If that embrace is ever to get beyond gestures and lip service, the FDA will need to change its rules and culture.