I appreciate the remarks and understand the concerns expressed by my colleagues. I agree that patients should not have to wait for promising new therapies due to insufficient resources at FDA. Language in the report accompanying the Senate bill states that the increase received by FDA's Devices and Radiological Health Program for fiscal year 2002 is consistent with agency estimates for bringing medical device application review times within statutory limits. While this statement is accurate according to the budget submitted to congress by the FDA, I have been informed that in testimony to the House Appropriations Committee, FDA officials stated the agency would need more funds than requested in their budget to decrease application review times significantly. I believe it is important for us to work together to resolve this issue, and look forward to working with my colleagues and our House counterparts in the Conference Committee.
Herb Kohl: “I appreciate the remarks and understand the concerns expressed by my colleagues. I agree that patients should not have…”
On the recordOctober 30, 2001
Source
govinfo.govEditor's note · Context
Discussing funding and resource needs for the FDA to improve medical device application review times.
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