FDA Review of Drug Applications (Government Procedures and Operations) - Softcover

Softcover

ISBN 10: 162257771X ISBN 13: 9781622577712

Verlag: Nova Science Publishers Inc, 2013

Inhaltsangabe

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.

Details zur Ausgabe

• Verlag: Nova Science Publishers Inc
• Erscheinungsdatum: 2013
• Sprache: Englisch
• ISBN 10: 162257771X
• ISBN 13: 9781622577712
• Einband: Taschenbuch
• Anzahl der Seiten: 95
• Herausgeber: Cooperman Morris, Porter Richard J.
• Kontakt zum Hersteller: Nicht verfügbar
• Verantwortliche Person: eucomply OÜ; hello@eucompliancepartner.com; ; Pärnu mnt 139b-14; Tallinn; 11317; Estland