FDA Regulatory Affairs : A Guide for Prescription Drugs, Medical Devices, and Biologics PDF
Edited by Douglas J. Pisano, David S. (Cubist Pharmaceuticals, Lexington, Massachusetts, USA) Mantus
Description
Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing.
The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements.
Written in
Information
-
Download - Immediately Available
- Format:PDF
- Pages:464 pages
- Publisher:Taylor & Francis Inc
- Publication Date:11/08/2008
- Category:
- ISBN:9781420073553
Information
-
Download - Immediately Available
- Format:PDF
- Pages:464 pages
- Publisher:Taylor & Francis Inc
- Publication Date:11/08/2008
- Category:
- ISBN:9781420073553