1 Overview of FDA and drug development Josephine C. Babiarz Babiarz, Josephine C. Douglas J. Pisano Pisano, Douglas J. 1
2 What is an IND? Michael R. Hamrell Hamrell, Michael R. 33
3 The new drug application Charles Monahan Monahan, Charles Josephine C. Babiarz Babiarz, Josephine C. 69
4 Meeting with the FDA Alberto Grignolo Grignolo, Alberto 109
5 FDA medical device regulation Barry Sall Sall, Barry 125
6 The development of orphan drugs Tan T. Nguyen Tan, T. Nguyen 167
7 CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval stages Prabu Nambiar Nambiar, Prabu Steven R. Koepke Koepke, Steven R. 187
8 Overview of the GxPs for the regulatory professional Bob Buckley Buckley, Bob Robert Blanks Blanks, Robert 213
9 FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices Karen L. Drake Drake, Karen L. 267
10 Electronic submissions - a guide for electronic regulatory submissions to FDA Shylendra Kumar Kumar, Shylendra Yolanda Hall Hall, Yolanda Vahe Ghahraman Ghahraman, Vahe 289
11 The practice of regulatory affairs David S. Mantus Mantus, David S. 351
12 A primer of drug/device law : what's the law and how do I find it? Josephine C. Babiarz Babiarz, Josephine C. 369
13 FDA advisory committees Christina A. McCarthy McCarthy, Christina A. David S. Mantus Mantus, David S. 397
14 Biologics Timothy A. Keutzer Keutzer, Timothy A. 417
Index 435
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