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FDA Regulatory Affairs: Third Edition
Examines harmonization of US Federal Food, and Cosmetic Act with international regulations as they apply to human drug and device development, research, and marketing. Focusing on drug approval process, cGMPs, GCPs, quality system compliance, and documentation requirements, this title is suitable for those involved in pharmaceutical regulation.
| Author(s) | Edited by David Mantus (Sention, Providence, Rhode Island, USA), Douglas J. Pisano. |
|---|---|
| Publisher | Taylor & Francis Ltd |
| Format | Hardback |
| Pages | 400 |
| Published in | United Kingdom |
| Published | 28 Feb 2014 |
| Availability | Available |
Examines harmonization of US Federal Food, and Cosmetic Act with international regulations as they apply to human drug and device development, research, and marketing. Focusing on drug approval process, cGMPs, GCPs, quality system compliance, and documentation requirements, this title is suitable for those involved in pharmaceutical regulation.
Overview of FDA and Drug Development. What Is an IND? The New Drug Application. Meetings with the FDA. FDA Medical Device Regulation. A Primer of Drug/Device Law: What Is the Law and How Do I Find It? The Development of Orphan Drugs. CMC Sections of Regul
David Mantus worked in the biotechnology and pharmaceutical industry for more than 20 years. He not only served as vice president of regulatory affairs at Cubist Pharmaceuticals but also held various regulatory roles at Sention Inc., Shire Biologics, PARE
