ABSTRACT

Within the drug development process, there have already been several U.S. Food and Drug Administration (FDA)–approved PGx diagnostics (genetic tests), and drugs for which there is PGx information in their labels [4]. Moreover, there has been oversight by the regulatory authorities over this eld since 2004 and in the white paper titled Innovation or

CONTENTS

5.1 The Vision: Pharmacogenomics and Personalized Medicine ..................................... 121 5.2 The Need for Pharmacogenomics Knowledge to Support Personalized Medicine ......125 5.3 Major Sources of Pharmacogenomics Knowledge ........................................................ 127 5.4 Bridging the Gap between the Current State of Pharmacogenomics Knowledge

and Its Integration .............................................................................................................. 130 References ..................................................................................................................................... 131

Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products [5], attention was brought to how emerging PGx techniques showed promise for improving on the safety, efcacy, and quality of drug products. Subsequently, in 2005, the FDA published the white paper Guidance for Industry on Pharmacogenomics Data Submission [6], with the goal of promoting the use of PGx in drug development and encouraging public sharing of data and information on PGx test results.