FDA Review of Drug Applications

FDA Review of Drug Applications

Author: Morris Cooperman

Publisher: Nova Science Pub Incorporated

ISBN: 162257771X

Category: Political Science

Page: 85

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In the late 1980s, the median time for FDA to approve a new drug application (NDA) was 29 months. Industry, consumer groups, and FDA agreed that the time from submission of a drug or biologics application to FDA's decision was unacceptably long. Patient advocates argued that a drug in review--and therefore not available for sale -- could be the difference between life and death. Manufacturers argued that prolonged review times affected their ability to recoup the costs of research and development. This book examines the FDA's review of drug applications, with a focus on the Prescription Drug User Fee Act (PDUFA) and issues for reauthorization in 2012.
Off-label Drug Use and FDA Review of Supplemental Drug Applications
Language: en
Pages: 152
Authors: United States, United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources and Intergovernmental Relations
Categories: Digital images
Type: BOOK - Published: 1997 - Publisher:

Books about Off-label Drug Use and FDA Review of Supplemental Drug Applications
FDA Review of Drug Applications
Language: en
Pages: 85
Authors: Morris Cooperman, Richard J. Porter
Categories: Political Science
Type: BOOK - Published: 2013-01-01 - Publisher: Nova Science Pub Incorporated

In the late 1980s, the median time for FDA to approve a new drug application (NDA) was 29 months. Industry, consumer groups, and FDA agreed that the time from submission of a drug or biologics application to FDA's decision was unacceptably long. Patient advocates argued that a drug in review--and
Review of Enforcement and Certification Activities of the Food Drug Administration, Department of Health, Education, and Welfare, September 1960
Language: en
Pages: 74
Authors: United States. General Accounting Office
Categories: Political Science
Type: BOOK - Published: 1961 - Publisher:

Books about Review of Enforcement and Certification Activities of the Food Drug Administration, Department of Health, Education, and Welfare, September 1960
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2011
Language: en
Pages:
Authors: United States. Congress. House. Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Categories: United States
Type: BOOK - Published: 2010 - Publisher:

Books about Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2011
Prescription Drugs
Language: en
Pages: 62
Authors: U S Government Accountability Office (G, U. S. Government Accountability Office (
Categories: United States
Type: BOOK - Published: 2013-06 - Publisher: BiblioGov

Pursuant to a congressional request, GAO provided information on the Food and Drug Administration's (FDA) review and approval of drug manufacturers' applications to market seven drugs that would be covered by H.R. 1598 and S.1172, focusing on: (1) the review and approval times for the seven pipeline drugs in comparison