Zdrowie i gospodarka · 11/07/2014

FDA Releases Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Prior Approval Supplements Under the Generic Drug User Fee Amendments of 2012

The Food and Drug Administration (FDA) has published a draft guidance document to help pharmaceutical companies prepare for prior approval supplements and amendments to abbreviated new drug applications (ANDAs) under the Generic Drug User Fee Amendments of 2012 (GDUFA), which allows the FDA to charge user fees to fund improvements to its generic drugs program.