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

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__**: * provides a blueprint to the FDA and drug, biologic, and medical device development * offers current, real-time information in a simple and concise format * contains a chapter highlighting the new drug application (NDA) process * discusses FDA inspection processes and enforcement options * includes contributions from experts at companies such as Millennium and Genzyme, leading CRO’s such as PAREXEL and the Biologics Consulting Group, and the FDA Three all-new chapters cover: * clinical trial exemptions * advisory committees * provisions for fast track

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:

• provides a blueprint to the FDA and drug, biologic, and medical device development
• offers current, real-time information in a simple and concise format
• contains a chapter highlighting the new drug application (NDA) process
• discusses FDA inspection processes and enforcement options
• includes contributions from experts at companies such as Millennium and Genzyme, leading CRO’s such as PAREXEL and the Biologics Consulting Group, and the FDA

Three all-new chapters cover:

• clinical trial exemptions
• advisory committees
• provisions for fast track

Content: Overview of FDA and drug development / Josephine C. Babiarz and Douglas J. Pisano -- What is an IND / Charles Monahan and Josephine C. Babiarz -- Meeting with the FDA / Alberto Grignolo -- FDA medical device regulation / Barry Sall -- The development of orphan drugs / Tan T. Nguyen -- CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval states / Prabu Nambiar and Steven R. Koepke -- Overview of the GxPs for the regulatory professional / Bob Buckley and Robert Blanks -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- Electronic submissions--a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, and Vahé Ghahraman -- The practice of regulatory affairs / David S. Mantus -- A primer of drug/device law : what's the law and how do I find it / Josephine C. Babiarz -- FDA advisory committees / Christina A. McCarthy and David S. Mantus -- Biologics / Timothy A. Keutzer. Overview of drug development and the FDA / Josephine Babiarz IND / Michael R. Hamrell Formatting, assembling, and submitting a CTD (NDA) / Charles Monahan III Meeting with the FDA / Alberto Grignolo Biologics / J. Kenimer FDA medical device regulation / Barry Sall The development of orphan drugs / Tan Nguyen Combination products / Tara Dunn Chemistry, manufacturing, and control issues: drugs and biologics / Prabu Nambiar Good clinical practices, good manufacturing practices, and good laboratory practices / Robert Buckley The regulation of promotional materials and advertising for drugs / Karen Drake CTD submissions: a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, Vah Ghahraman The practice of regulatory affairs / Dave Mantus A primer of drug/device law or what's the law and how do I find it? / Josephine Babiarz Advisory committee system at FDA / Christina McCarthy. Preface 6 Contents 8 1 Overview of FDA and Drug Development 12 2 What Is an IND? 44 3 The New Drug Application 80 4 Meeting with the FDA 120 5 FDA Medical Device Regulation 136 6 The Development of Orphan Drugs 178 7 CMC Sections of Regulatory Filings and CMC Regulatory Compliance During Investigational and Postapproval Stages 198 8 Overview of the GxPs for the Regulatory Professional 224 9 FDA Regulation of the Advertising and Promotion of Prescription Drugs, Biologics, and Medical Devices 278 10 Electronic Submissions—A Guide for Electronic Regulatory Submissions to FDA 300 11 The Practice of Regulatory Affairs 362 12 A Primer of Drug/Device Law: What’s the Law and How Do I find It? 380 13 FDA Advisory Committees 408 14 Biologics 428 Index 446 "This book 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."--BOOK JACKET