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FDA Review of Drug Applications

By: (Edited by) Morris Cooperman , (Edited by) Richard J Porter

Extended Catalogue

Ksh 15,300.00

Format: Paperback / Softback

ISBN-10: 162257771X

ISBN-13: 9781622577712

Publisher: Nova Science Publishers Inc

Imprint: Nova Science Publishers Inc

Country of Manufacture: US

Country of Publication: GB

Publication Date: Mar 5th, 2013

Print length: 95 Pages

Weight: 160 grams

Dimensions (height x width x thickness): 15.30 x 22.70 x 0.60 cms

Product Classification: Public health & safety law

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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.

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