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FDA To See Increased Funding, Oversight From Approps Committees In 2007

Executive Summary

As the incoming chair of the House committee overseeing FDA's budget, Rep. Rosa DeLauro (D-Conn.) wants to increase agency funding - but not without the caveat of enhanced congressional oversight

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FDA “Failure” To Approve Generic Biologics Questioned By Commerce Cmte.

The House Energy and Commerce Committee appears to be gearing up to create legislation establishing a pathway for the approval of follow-on biologics

FDA “Failure” To Approve Generic Biologics Questioned By Commerce Cmte.

The House Energy and Commerce Committee appears to be gearing up to create legislation establishing a pathway for the approval of follow-on biologics

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)...

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