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.
Preface; Editors; Contributors; Chapter 1 Overview of FDA and Drug Development; Chapter 2 What Is an IND?; Chapter 3 The New Drug Application; Chapter 4 Meetings with the FDA; Chapter 5 FDA Medical Device Regulation; Chapter 6 A Primer of Drug/Device Law: What Is the Lawand How Do I Find It?; Chapter 7 The Development of Orphan Drugs; Chapter 8 CMC Sections of Regulatory Filings and CMC RegulatoryCompliance during Investigational and Postapproval Stages; Chapter 9 Overview of the GxPs for the Regulatory Professional; Chapter 10 FDA Regulation of the Advertising and Promotionof Prescription Drugs, Biologics, and Medical DevicesChapter 11 The Practice of Regulatory Affairs; Chapter 12 FDA Advisory Committees; Chapter 13 Biologics; Chapter 14 Regulation of Combination Products in the United States.
Description based on print version record.
Acquired for the Penn Libraries with assistance from the Clarence J. Marshall Memorial Library Fund.