Biologics Development: A Regulatory Overview

Mark P. Mathieu

ISBN 10: 1882615670 / ISBN 13: 9781882615674

Verlag: Barnett Educational Services /, 2004

Bestandsnummer des Verkäufers 1882615670-VB

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.

Bibliografische Details

Titel: Biologics Development: A Regulatory Overview
Verlag: Barnett Educational Services /
Erscheinungsdatum: 2004
Einband: hardcover
Zustand: As New
Auflage: 3. Auflage