Biologics Development: Regulatory Overview - Hardcover

Hardcover

ISBN 10: 1882615670 ISBN 13: 9781882615674

Verlag: Barnett Educational Services / Chi, 2004

Inhaltsangabe

This publication is the only text on Biologics Development and Regulation in the Post-CBER/CDER Consolidation Era. Completely revised and updated to address the transfer of therapeutic biological products to CDER, this all-new edition provides the most comprehensive and up-to-date analysis of the FDA's emerging processes for regulating and approving biological products. Written by CDER and CBER officials and industry experts, Biologics Development: A Regulatory Overview offers an expansive examination of the FDA's regulation of biologic products, from preclinical testing to post-marketing regulatory requirements, and from user fees to electronic submissions. Better yet, this new text provides the first detailed look inside the re-invented FDA that will regulate and approve today's biological products.

Details zur Ausgabe

• Verlag: Barnett Educational Services / Chi
• Erscheinungsdatum: 2004
• Sprache: Englisch
• ISBN 10: 1882615670
• ISBN 13: 9781882615674
• Einband: Gebundene Ausgabe
• Auflage: 3
• Anzahl der Seiten: 300
• Herausgeber: Mathieu Mark P.
• Kontakt zum Hersteller: Nicht verfügbar
• Verantwortliche Person: Nicht verfügbar