FDA Regulatory Affairs: A Guide for

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 FDAThree all-new chapters cover:clinical trial exemptions advisory committees provisions for fast track

Preface	p. iii
Contributors	p. vii
Overview of FDA and Drug Development	p. 1
What Is an IND?	p. 33
The New Drug Application	p. 69
Meeting with the FDA	p. 109
FDA Medical Device Regulation	p. 125
The Development of Orphan Drugs	p. 167
CMC Sections of Regulatory Filings and CMC Regulatory Compliance During Investigational and Postapproval Stages	p. 187
Overview of the GxPs for the Regulatory Professional	p. 213
FDA Regulation of the Advertising and Promotion of Prescription Drugs, Biologics, and Medical Devices	p. 267
Electronic Submissions-A Guide for Electronic Regulatory Submissions to FDA	p. 289
The Practice of Regulatory Affairs	p. 351
A Primer of Drug/Device Law: What's the Law and How Do I find It?	p. 369
FDA Advisory Committees	p. 397
Biologics	p. 417
Index	p. 435
Table of Contents provided by Ingram. All Rights Reserved.

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

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