Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period

Streszczenie

The Food and Drug Administration (FDA) is reopening until June 30, 2011, the comment period for the notice of public meeting, published in the Federal Register of August 9, 2010 (75 FR 47820), entitled "Generic Drug User Fee; Public Meeting; Request for Comments." In that notice, FDA announced a public meeting that took place on September 17, 2010, to gather stakeholder input on the development of a generic drug user fee program. FDA is reopening the comment period for the expected duration of the active negotiation phase to ensure that all interested stakeholders have the opportunity to share their views on the matter.