FDA Review of Drug Applications
Book Details
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
15.30 x 22.70 x 0.60 cms
Product Classification:
Public health & safety law
Ksh 15,300.00
Not available
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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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