Items related to FDA REVIEW OF DRUG APPLICATION (Government Procedures...

FDA REVIEW OF DRUG APPLICATION (Government Procedures and Operations) - Softcover

COOPERMAN M.

 
9781622577712: FDA REVIEW OF DRUG APPLICATION (Government Procedures and Operations)
Softcover
ISBN 10: 162257771X ISBN 13: 9781622577712
Publisher: Gazelle, 2013

Synopsis

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.

"synopsis" may belong to another edition of this title.

Publisher
Gazelle
Publication date
2013
Language
English
ISBN 10 
162257771X
ISBN 13 
9781622577712
Binding
Paperback
Number of pages
1