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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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PRINTED FROM COLUMBIA SCHOLARSHIP ONLINE (www.columbia.universitypressscholarship.com). (c) Copyright University of Minnesota Press, 2021. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in CUPSO for personal use.date: 05 August 2021

A New Regulatory Function for E-Prescriptions

A New Regulatory Function for E-Prescriptions

Linking FDA to Physicians and Patient Records

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

Andrew English

David Rosenberg

Huaou Yan

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231171182.003.0034

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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