FDA Regulatory Affairs
| Author | : Douglas J. Pisano |
| Publisher | : CRC Press |
| Total Pages | : 466 |
| Release | : 2008-08-11 |
| ISBN-10 | : 9781040061978 |
| ISBN-13 | : 1040061974 |
| Rating | : 4/5 (974 Downloads) |
Book Synopsis FDA Regulatory Affairs by : Douglas J. Pisano
Download or read book FDA Regulatory Affairs written by Douglas J. Pisano and published by CRC Press. This book was released on 2008-08-11 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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