FDA Regulatory Affairs: Third Edition 2014

• Serves as a roadmap to prescription drug, biologics, and medical device development in the United States
• Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations
• Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL
• Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and documentation requirements
• Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating guidelines from the 2012 Prescription Drug User Fee Act (PDUFA) V
• Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions

 

Summary

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more.

The Third Edition of this highly successful publication:

 

• Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing
• Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL
• Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements
• Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V
• Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions

 

Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.

Preface

Editors

Contributors

Overview of FDA and Drug Development
Josephine C. Babiarz and Douglas Pisano

What Is an IND?
Michael R. Hamrell

The New Drug Application
Charles Monahan and Josephine C. Babiarz

Meetings with the FDA 
Alberto Grignolo and Sally Choe

FDA Medical Device Regulation
Barry Sall

A Primer of Drug/Device Law: What Is the Law and How Do I Find It? 
Josephine C. Babiarz

The Development of Orphan Drugs
Scott N. Freeman

CMC Sections of Regulatory Filings and CMC Regulatory Compliance during Investigational and Postapproval Stages 
Prabu Nambiar, Steven R. Koepke, and Kevin Swiss

Overview of the GxPs for the Regulatory Professional
Bob Buckley, Robert Blanks, Kimberly J. White, and Tonya White-Salters

FDA Regulation of the Advertising and Promotion of Prescription Drugs, Biologics, and Medical Devices 
Karen L. Drake, Esq.

The Practice of Regulatory Affairs
David S. Mantus

FDA Advisory Committees
Christina A. McCarthy and David S. Mantus

Biologics
Florence Kaltovich

Regulation of Combination Products in the United States
John Barlow Weiner, Esq.

Index