Zdrowie i gospodarka · 27/08/2012
Generic Drug User Fee Amendments of 2012; Public Meeting; Request for Comments
The Food and Drug Administration (FDA) is announcing a public meeting to discuss implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA). GDUFA requires that generic drug manufacturers pay user fees to finance critical and measurable generic drug program enhancements and also requires that generic drug facilities, sites, and organizations around the world provide identification information annually to FDA. The purpose of the public meeting is to discuss recent communications concerning GDUFA implementation and to provide an opportunity for the public to present views on these materials.