FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics
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- Synopsis
- 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
- Copyright:
- 2008
Book Details
- Book Quality:
- Publisher Quality
- ISBN-13:
- 9781040061978
- Related ISBNs:
- 9781420073553, 9780429126062, 9781420073546, 9781135436049
- Publisher:
- CRC Press
- Date of Addition:
- 06/16/24
- Copyrighted By:
- Taylor & Francis Group, LLC
- Adult content:
- No
- Language:
- English
- Has Image Descriptions:
- No
- Categories:
- Nonfiction, Science, Medicine
- Submitted By:
- Bookshare Staff
- Usage Restrictions:
- This is a copyrighted book.
- Edited by:
- Douglas J. Pisano
- Edited by:
- David S. Mantus
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- by Douglas J. Pisano
- by David S. Mantus
- in Nonfiction
- in Science
- in Medicine