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. It focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements.

FDA Regulatory Affairs draws information from a wide range of resources and demystifies the inner workings of the FDA, facilitating an understanding of how it operates in terms of compliance and product approval.

FDA Regulatory Affairs includes:

• a blueprint to the FDA and drug, biologic, and medical device development
• current, real-time information
• the new drug application (NDA) process
• FDA inspection processes and enforcement options
• 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 new chapters cover:

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

Contents

1. Overview of FDA and Drug Development
2. What Is an IND?
3. The New Drug Application
4. Meeting with the FDA
5. FDA Medical Device Regulation
6. The Development of Orphan Drugs
7. CMC Sections of Regulatory Filings and CMC Regulatory Compliance During Investigational and Postapproval Stages
8. Overview of the GxPs for the Regulatory Professional
9. FDA Regulation of the Advertising and Promotion of Prescription Drugs, Biologics, and Medical Devices
10. Electronic Submissions—A Guide for Electronic Regulatory Submissions to FDA
11. The Practice of Regulatory Affairs
12. A Primer of Drug/Device Law: What’s the Law and How Do I find It?
13. FDA Advisory Committees
14. Biologics

Index

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