Generic User Fees Face Opposition From Key House Appropriator DeLauro
Executive Summary
The chairwoman of the House subcommittee that oversees funding for FDA does not support user fees to finance reviews of generic drug applicationsYou may also be interested in...
Generic Drug Fees Could Be Based On Product Complexity
FDA seeks comments at Sept. 17 public hearing on issues surrounding development of an ANDA user fee program, including whether applications for more complex products should carry a higher fee and whether fees should be used to support postmarketing safety oversight.
Avandia Aftershocks: Will FDA Drug Safety Review Structures Crumble?
Rep. Rosa DeLauro's, D-Conn., hearing on the safety of GlaxoSmithKline's diabetes drug Avandia has ratcheted up the pressure on FDA to make broad reforms of its review structure, but the congresswoman has been careful not to urge a particular course of action for the agency
Avandia Aftershocks: Will FDA Drug Safety Review Structures Crumble?
Rep. Rosa DeLauro's, D-Conn., hearing on the safety of GlaxoSmithKline's diabetes drug Avandia has ratcheted up the pressure on FDA to make broad reforms of its review structure, but the congresswoman has been careful not to urge a particular course of action for the agency
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