BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 9.08.2010

Generic Drug User Fee; Public Meeting; Request for Comments

The Food and Drug Administration (FDA) is announcing a public meeting to gather stakeholder input on the development of a generic drug user fee program. The number of human generic drug applications awaiting FDA action and the median review times for generic drug applications have increased in recent years. A user fee program could provide necessary supplemental funding, in addition to current Congressional appropriations, to allow for the timely review of such applications. Although the President's Fiscal Year (FY) 2011 budget includes generic drug user fees, new legislation would be required for FDA to establish and collect user fees under such a program. As FDA begins negotiations with the regulated industry about generic drug user fees, FDA will hold a public meeting to gather the public's input on such a program. Date and Time: The public meeting will be held on September 17, 2010, from 9 a.m. to 5 p.m. Location: The meeting will be held at the Hilton Washington DC/ Rockville and Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. Contact Persons: Mary C. Gross, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bld

Source: Federal Register — Health and Human ServicesOpen original release →