The Lacuna Project

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Exhibit 1283

Food and Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities (GAO-02-958)

Exhibit 1283 ยท GAO report

Food and Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities (GAO-02-958)

user fees funded 7 percent of drug and biologic review obligations in fiscal year 1993, user fees accounted for nearly 50 percent of the total funds obligated for the drug and biologic review processes in fiscal year 2001.

GAO reports the share of FDA's drug and biologic review obligations paid from user fees: 7 percent in fiscal year 1993, nearly 50 percent in fiscal year 2001, and 51 percent expected for fiscal year 2002.

Source
U.S. General Accounting Office
Date
September 2002
Quoted from
GAO-02-958, printed p. 8 (section 'PDUFA Has Increased Funding and Reduced Drug Approval Time...')
Grade
Primary record
Document
https://files.gao.gov/assets/gao-02-958.pdf
Accessed
2026-11-10
Cited by
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