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FDA Issues Draft Guidance to Foster Competitive Access for Bioequivalence Studies

The guidance seeks to help generic and biosimilar drug sponsors gain access to reference products from brand-name manufacturers.
Published Date: 
December 4, 2014
URL: 
http://www.pharmtech.com/pharmtech/News/FDA-Issues-Draft-Guidance-to-Foster-Competitive-Ac/ArticleStandard/Article/detail/862894?contextCategoryId=35097&ref=25
Title: 
FDA Issues Draft Guidance to Foster Competitive Access for Bioequivalence Studies
Short Description: 
The guidance seeks to help generic and biosimilar drug sponsors gain access to reference products from brand-name manufacturers.