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FDA in the Twenty-First CenturyThe Challenges of Regulating Drugs and New Technologies$
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Holly Fernandez Lynch and I. Glenn Cohen

Print publication date: 2015

Print ISBN-13: 9780231171182

Published to Columbia Scholarship Online: May 2016

DOI: 10.7312/columbia/9780231171182.001.0001

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A New Regulatory Function for E-Prescriptions

A New Regulatory Function for E-Prescriptions

Linking FDA to Physicians and Patient Records

(p.486) Chapter Twenty-Six A New Regulatory Function for E-Prescriptions
FDA in the Twenty-First Century

Andrew English

David Rosenberg

Huaou Yan

Columbia University Press

This chapter proposes deploying electronic prescription technology as an interface connecting the FDA with physicians and patient records to enhance its regulation of medical product usage. Such an e-prescription platform would enable the Agency both (1) to directly and immediately provide physicians with salient warnings, advisories, and best-practice protocols at the time they prescribe treatment and (2) to monitor and elicit compliance, product usage (including off-label usage), and treatment-result information that will comprise a comprehensive, systematic, and real-time databank for facilitating more reliable and expeditious oversight and regulation.

Keywords:   e-prescription, adverse reaction, off-label, post-market, surveillance, monitor

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