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FDA Review of Drug Applications
Engelsk Paperback
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FDA Review of Drug Applications

Engelsk Paperback

897 kr
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Om denne bog
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.
Product detaljer
Sprog:
Engelsk
Sider:
95
ISBN-13:
9781622577712
Indbinding:
Paperback
Udgave:
ISBN-10:
162257771X
Kategori:
Udg. Dato:
5 mar 2013
Længde:
6mm
Bredde:
227mm
Højde:
153mm
Forlag:
Nova Science Publishers Inc
Oplagsdato:
5 mar 2013
Forfatter(e):
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