{"title":"美国对组合产品的监管。","authors":"Maria Donawa","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>The successful launch ofa combination product in the United States (US) will depend on how well a company understands applicable US regulations and policies, which differ in important ways from requirements in Europe. This article provides an overview of useful information on the US regulation of these products that can be found on the newly redesigned Food and Drug Administration website.</p>","PeriodicalId":80066,"journal":{"name":"Medical device technology","volume":"20 6","pages":"22, 24-5"},"PeriodicalIF":0.0000,"publicationDate":"2009-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"US regulation of combination products.\",\"authors\":\"Maria Donawa\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The successful launch ofa combination product in the United States (US) will depend on how well a company understands applicable US regulations and policies, which differ in important ways from requirements in Europe. This article provides an overview of useful information on the US regulation of these products that can be found on the newly redesigned Food and Drug Administration website.</p>\",\"PeriodicalId\":80066,\"journal\":{\"name\":\"Medical device technology\",\"volume\":\"20 6\",\"pages\":\"22, 24-5\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2009-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Medical device technology\",\"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":"Medical device technology","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
The successful launch ofa combination product in the United States (US) will depend on how well a company understands applicable US regulations and policies, which differ in important ways from requirements in Europe. This article provides an overview of useful information on the US regulation of these products that can be found on the newly redesigned Food and Drug Administration website.
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