FDA Review of Drug Applications

Morris Cooperman, Richard J Porter (Herausgeber)

Buch | Softcover

95 Seiten

2013
Nova Science Publishers Inc (Verlag)
978-1-62257-771-2 (ISBN)

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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.

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.

Verlagsort	New York
Sprache	englisch
Maße	155 x 230 mm
Gewicht	154 g
Themenwelt	Recht / Steuern ► EU / Internationales Recht
Themenwelt	Recht / Steuern ► Privatrecht / Bürgerliches Recht ► Medizinrecht
ISBN-10	1-62257-771-X / 162257771X
ISBN-13	978-1-62257-771-2 / 9781622577712
Zustand	Neuware