President’s Budget Paves The Critical Path With $6 Mil. Request
Executive Summary
FDA requests $6 mil. and six FTEs for its Critical Path initiative in fiscal 2007, marking the first time funding has been proposed for the program
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“Critical Path” Is On The Road Forward; FDA Reports Industry Activity Is High
The Critical Path Initiative is entering 2007 with growing momentum, bolstered by a new, tailored agency infrastructure and increased industry awareness of FDA's initiative to spur drug development
“Critical Path” Is On The Road Forward; FDA Reports Industry Activity Is High
The Critical Path Initiative is entering 2007 with growing momentum, bolstered by a new, tailored agency infrastructure and increased industry awareness of FDA's initiative to spur drug development
Generic review appropriations
The Senate Agriculture Appropriations bill reported by the full appropriations committee June 22 includes $10 mil. more for generic drug reviews than in the president's request. It exceeds the House version by $5 mil. The committee requests that FDA submit a report on any changes that have been made to the generic drug approval process. If the funding survives conference, it could end recently reignited debate over generic drug user fees (1"The Pink Sheet" Feb. 27, 2006, p. 8). The Senate bill fully funds the president's request for an additional $6 mil. for the Critical Path initiative and $4 mil. for drug safety activities (2"The Pink Sheet" Feb. 13, 2006, p. 9)...