FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

ISBN-13: 9781420073546 / Angielski / Twarda / 2008 / 464 str.

Douglas J. Pisano; David S. Mantus

Opis

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 a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.

"FDA Regulatory Affairs":

Spis treści

1. Overview of Drug Development and the FDA. 2. IND. 3. Formatting, Assembling, And Submitting A CTD (NDA). 4. Meeting with the FDA. 5. Biologics. 6. FDA Medical Device Regulation. 7. The Development of Orphan Drugs. 8. Chemistry, Manufacturing and Control Issues: Drugs and Biologics. 9. Good Clinical Practices, Good Manufacturing Practices, and Good Laboratory Practices. 10. The Regulation of Promotional Materials and Advertising for Drugs. 11. CTD Submissions: A Guide for Electronic Regulatory Submissions to FDA. 12. The Practice of Regulatory Affairs. 13. A Primer Of Drug/Device Law Or What's The Law And How Do I Find It? 14. Advisory Committee System at FDA.