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FDA Review of Drug Applications

FDA Review of Drug Applications

9781622577712
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Description
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 FDAs 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 FDAs review of drug applications, with a focus on the Prescription Drug User Fee Act (PDUFA) and issues for reauthorization in 2012.
Product Details
Nova Science Publishers Inc
74021
9781622577712
9781622577712

Data sheet

Publication date
2013
Issue number
1
Cover
paperback
Pages count
95
Dimensions (mm)
155.00 x 230.00
Weight (g)
154
  • Preface; Prescription Drug User Fee Act (PDUFA):: Issues for Reauthorization (PDUFA V) in 2012; Prescription Drugs:: FDA Has Met Most Performance Goals for Reviewing Applications; Index.
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