Food and Drug Administration : effect of user fees on drug approval times, withdrawals, and other agency activities : report to the chairman, Committee on Health, Education, Labor, and Pensions, U.S. Senate

Food and Drug Administration : effect of user fees on drug approval times, withdrawals, and other agency activities : report to the chairman, Committee on Health, Education, Labor, and Pensions, U.S. Senate PDF Author:
Publisher: DIANE Publishing
ISBN: 1428944745
Category :
Languages : en
Pages : 36

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Food and Drug Administration

Food and Drug Administration PDF Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Fees, Administrative
Languages : en
Pages : 32

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Food and Drug Administration

Food and Drug Administration PDF Author: United States Government Accountability Office
Publisher: Createspace Independent Publishing Platform
ISBN: 9781985006997
Category :
Languages : en
Pages : 36

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Food and Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities

User Fees for the Food and Drug Administration

User Fees for the Food and Drug Administration PDF Author: United States. Congress. Senate. Committee on Labor and Human Resources
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 72

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Food And Drug Administration

Food And Drug Administration PDF Author: Janet Heinrich
Publisher: DIANE Publishing
ISBN: 9780756742898
Category : Medical
Languages : en
Pages : 51

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In 1992, the Prescription Drug User Fee Act (PDUFA) was enacted to provide additional resources for the FDA to speed up the process of reviewing applications for new drugs & biological products. This report examines: (1) how PDUFA has affected the funding & approval times for FDA's review of new drug & biologic applications, (2) whether PDUFA has had an effect on the funding & oper. of FDA's non-PDUFA activities, (3) whether the workload, attrition, & non-professional development of FDA reviewers have changed since the user fee program was reauthorized in 1997, & (4) how the rate of drug withdrawals from the market has changed since PDUFA was enacted in 1992 & what actions are being taken by FDA to monitor adverse drug effects. Charts & tables.

FDA User Fees

FDA User Fees PDF Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 50

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FDA User Fees

FDA User Fees PDF Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher:
ISBN:
Category : Drug approval
Languages : en
Pages : 96

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Drug User Fees

Drug User Fees PDF Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 96

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FDA User Fee Agreements

FDA User Fee Agreements PDF Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher:
ISBN:
Category : Drug approval
Languages : en
Pages : 88

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To Assess the Impact of Proposed FDA User Fees on Small Business

To Assess the Impact of Proposed FDA User Fees on Small Business PDF Author: United States. Congress. Senate. Committee on Small Business
Publisher:
ISBN:
Category : Small business
Languages : en
Pages : 132

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