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

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. regulatory professional, electronic submissions, medical device regulation, orphan drug regulations, regulatory affairs, quality systems approach, applicability statement, clinical safety data management, user fee cover sheet, device name, success criteria, medical device clinical research, biologic trials, draft guidance titled, medically plausible subset, violative materials, common bookmarks, advisory committee system, design control provisions, electronic regulatory submissions, orphan designation, designation request, prevalence threshold, medical device studies, clinical hold