Impact of regulations on artificial organs research

Impact of regulations on artificial organs research

From a research perspective, some of the primary problems created by the FDA regulations include: the amount of time necessary to comply with the regulations and to obtain FDA and IRB review of the studies. The cost of such delays may be great in terms of statistical death. Lack of understanding of...

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Veröffentlicht in:Transactions - American Society for Artificial Internal Organs 1983, Vol.29, p.770-773
Hauptverfasser: Morton, W A, DeVries, W C, Dobelle, W H, Serkes, K D, Sheridan, R, Dennis, C
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Artificial Organs - standards
Heart, Artificial - standards
Humans
Legislation as Topic
United States
United States Food and Drug Administration
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container_title Transactions - American Society for Artificial Internal Organs
container_volume 29
creator Morton, W A
DeVries, W C
Dobelle, W H
Serkes, K D
Sheridan, R
Dennis, C
description From a research perspective, some of the primary problems created by the FDA regulations include: the amount of time necessary to comply with the regulations and to obtain FDA and IRB review of the studies. The cost of such delays may be great in terms of statistical death. Lack of understanding of the regulations on the part of investigators. Escalated costs and extra restrictions on the use of animals. Benefits of the regulations appear to be: better preclinical testing performed prior to initiating clinical trials, and improved testing protocols, both of which may result in lower risks to patients.
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source MEDLINE; Journals@Ovid Complete
subjects Artificial Organs - standards
Heart, Artificial - standards
Humans
Legislation as Topic
United States
United States Food and Drug Administration
title Impact of regulations on artificial organs research
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