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Comparative Effectiveness ResearchEvidence, Medicine, and Policy$
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Carol M. Ashton and Nelda P. Wray

Print publication date: 2013

Print ISBN-13: 9780199968565

Published to Oxford Scholarship Online: September 2013

DOI: 10.1093/acprof:oso/9780199968565.001.0001

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The Use of Evidence

The Use of Evidence

Federal Regulation of Prescription Drugs and Medical Devices

Chapter:
(p.28) 2 The Use of Evidence
Source:
Comparative Effectiveness Research
Author(s):

Carol M. Ashton

Nelda P. Wray

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780199968565.003.0002

The U.S. Food and Drug Administration is statutorily responsible for ensuring that prescription drugs and medical devices meet evidential standards for safety and efficacy before they are approved for marketing. Nevertheless, serious evidential gaps remain for every product at the time of approval, more so for devices than drugs, and post-approval uptake is driven more by market forces than scientific evidence of superiority. Moreover, to obtain approval for marketing, medical product makers not statutorily required to evaluate the comparative effectiveness of their products, and infrequently have a business case to do so. Federally-mandated comparative effectiveness research will complement what is known about the safety and efficacy of approved pharmaceutical products and devices, a prospect that many in the medical products industry find threatening.

Keywords:   Food and Drug Administration, Drug approval process, Phase 1, 2, 3 trials, Direct-to-consumer marketing, 1976 Medical Device Amendments, Class I, II, and III medical devices, Premarket notification [510(k)] pathway, Premarket application (PMA) pathway, Off-label use, Da Vinci Surgical System® (robot) of Intuitive Surgical, Inc

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