Personalized Medicine and the FDA’s Emerging Role

Janette Scacco (Editor)

Series: Government Procedures and Operations
BISAC: MED000000



Volume 10

Issue 1

Volume 2

Volume 3

Special issue: Resilience in breaking the cycle of children’s environmental health disparities
Edited by I Leslie Rubin, Robert J Geller, Abby Mutic, Benjamin A Gitterman, Nathan Mutic, Wayne Garfinkel, Claire D Coles, Kurt Martinuzzi, and Joav Merrick


Digitally watermarked, DRM-free.
Immediate eBook download after purchase.

Product price
Additional options total:
Order total:



Over the past few years, a number of products that signal a new era of medical product development have entered the market or come on the horizon. Recently, the FDA approved four cancer drugs for use in patients whose tumors have specific genetic characteristics that are identified by a companion diagnostic test. This book describes the ways in which FDA has worked to respond to, anticipate and help drive scientific developments in personalized therapeutics and diagnostics.

It provides a compendium of FDA’s many recent efforts to advance regulatory standards, methods and tools in support of personalized medicine and to further refine critical regulatory processes and policies in order to bring about personalized medical product development. This thoughtful book should serve as a useful resource for those looking toward a future where all stages of patient care—from prevention to diagnosis to treatment to follow-up—are truly personalized. (Imprint: Novinka )


Chapter 1 - Paving the Way for Personalized Medicine: FDA‘s Role in a New Era of Medical Product Development (pp. 1-74)
U.S. Food and Drug Administration

Chapter 2 - FDA Regulation of Medical Devices (pp. 75-112)
Judith A. Johnson


You have not viewed any product yet.