{"title":"FDA准备新的生物仿制药指南和用户费用计划:药物互换性和用户费用是FDA必须解决的有争议的问题。FDA能胜任这项任务吗?","authors":"Stephen Barlas","doi":"","DOIUrl":null,"url":null,"abstract":"","PeriodicalId":89534,"journal":{"name":"Biotechnology healthcare","volume":"9 2","pages":"28-9"},"PeriodicalIF":0.0000,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3411228/pdf/bh0902028.pdf","citationCount":"0","resultStr":"{\"title\":\"FDA Readies New Guidance and User Fee Program for Biosimilars: Drug interchangeability and user fees are contentious issues the FDA must resolve. Is the FDA up to the task?\",\"authors\":\"Stephen Barlas\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"\",\"PeriodicalId\":89534,\"journal\":{\"name\":\"Biotechnology healthcare\",\"volume\":\"9 2\",\"pages\":\"28-9\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2012-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3411228/pdf/bh0902028.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Biotechnology healthcare\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biotechnology healthcare","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
FDA Readies New Guidance and User Fee Program for Biosimilars: Drug interchangeability and user fees are contentious issues the FDA must resolve. Is the FDA up to the task?