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FDA Review of Drug Applications
Morris Cooperman
€ 99.95
€ 69.24
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Description for FDA Review of Drug Applications
Paperback. Editor(s): Cooperman, Morris; Porter, Richard J. Num Pages: 95 pages, illustrations. BIC Classification: 1KBB; LNTJ. Category: (P) Professional & Vocational. Dimension: 153 x 227 x 6. Weight in Grams: 156.
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 ... Read more
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 ... Read more
Product Details
Publisher
Nova Science Publishers Inc United States
Number of pages
95
Format
Paperback
Publication date
2013
Condition
New
Number of Pages
95
Place of Publication
New York, United States
ISBN
9781622577712
SKU
V9781622577712
Shipping Time
Usually ships in 5 to 9 working days
Ref
99-2
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