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Open AccessFeature PaperCommunication
Diseases 2018, 6(1), 2; https://doi.org/10.3390/diseases6010002

Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics

1
School of Biomedical Engineering, Colorado State University, Fort Collins, CO 80523, USA
2
Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA
3
Department of Biology, Colorado State University, Fort Collins, CO 80523, USA
4
Department of Mechanical Engineering, Colorado State University, Fort Collins, CO 80523, USA
5
Department of Microbiology, Immunology, and Pathology, Colorado State University, Fort Collins, CO 80523, USA
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Walter Scott College of Engineering, Colorado State University, Fort Collins, CO 80523, USA
7
Department of Electrical and Computer Engineering, Colorado State University, Fort Collins, CO 80523, USA
8
Department of Biomaterials and Healthcare, Fraunhofer-Institute for Applied Polymer Research (IAP), Division of Life Science and Bioprocesses, 14476 Potsdam-Golm, Germany
9
Department of Clinical Sciences, Colorado State University, Fort Collins, CO 80523, USA
10
Cell and Molecular Biology Program, Colorado State University, Fort Collins, CO 80523, USA
11
Epidemiology Section, Colorado School of Public Health, Fort Collins, CO 80523, USA
*
Author to whom correspondence should be addressed.
Received: 7 November 2017 / Revised: 14 December 2017 / Accepted: 19 December 2017 / Published: 22 December 2017
(This article belongs to the Special Issue Pediatric Diseases)
View Full-Text   |   Download PDF [369 KB, uploaded 22 December 2017]   |  

Abstract

Over the past two decades, the biopharmaceutical industry has seen unprecedented expansion and innovation in concert with significant technological advancements. While the industry has experienced marked growth, the regulatory system in the United States still operates at a capacity much lower than the influx of new drug and biologic candidates. As a result, it has become standard for months or even years of waiting for commercial approval by the U.S. Food and Drug Administration. These regulatory delays have generated a system that stifles growth and innovation due to the exorbitant costs associated with awaiting approval from the nation’s sole regulatory agency. The recent re-emergence of diseases that impact pediatric demographics represents one particularly acute reason for developing a regulatory system that facilitates a more efficient commercial review process. Herein, we present a range of initiatives that could represent early steps toward alleviating the delays in approving life-saving therapeutics. View Full-Text
Keywords: FDA; commercial drug approval; privatization; windfall tax FDA; commercial drug approval; privatization; windfall tax
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Rykhus, R.D.; Shepard, Z.V.; Young, A.; Frisby, H.; Calder, K.A.; Coon, C.M.; Falk, J.A.; McAndrews, S.R.; Turner, A.; Chang, C.; Michelsohn, J.; Petch, R.; Dieker, S.M.; Markworth, B.H.; Alamo-Perez, K.; Hosack, A.J.; Berg, J.M.; Schmidt, C.; Storsberg, J.; Brown, M.A. Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics. Diseases 2018, 6, 2.

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