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

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...

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Autores principales: Rykhus, Ryan D., Shepard, Zachary V., Young, Alix, Frisby, Hadley, Calder, Kailee A., Coon, Collin M., Falk, Justin A., McAndrews, Sydney R., Turner, Aspen, Chang, Christina, Michelsohn, Johanna, Petch, Raegan, Dieker, Sarah M., Markworth, Benjamin H., Alamo-Perez, Kevin, Hosack, Aaron J., Berg, Jacob M., Schmidt, Christian, Storsberg, Joachim, Brown, Mark A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 0201
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5871948/
https://www.ncbi.nlm.nih.gov/pubmed/29271878
http://dx.doi.org/10.3390/diseases6010002
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author Rykhus, Ryan D.
Shepard, Zachary V.
Young, Alix
Frisby, Hadley
Calder, Kailee A.
Coon, Collin M.
Falk, Justin A.
McAndrews, Sydney R.
Turner, Aspen
Chang, Christina
Michelsohn, Johanna
Petch, Raegan
Dieker, Sarah M.
Markworth, Benjamin H.
Alamo-Perez, Kevin
Hosack, Aaron J.
Berg, Jacob M.
Schmidt, Christian
Storsberg, Joachim
Brown, Mark A.
author_facet Rykhus, Ryan D.
Shepard, Zachary V.
Young, Alix
Frisby, Hadley
Calder, Kailee A.
Coon, Collin M.
Falk, Justin A.
McAndrews, Sydney R.
Turner, Aspen
Chang, Christina
Michelsohn, Johanna
Petch, Raegan
Dieker, Sarah M.
Markworth, Benjamin H.
Alamo-Perez, Kevin
Hosack, Aaron J.
Berg, Jacob M.
Schmidt, Christian
Storsberg, Joachim
Brown, Mark A.
author_sort Rykhus, Ryan D.
collection PubMed
description 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.
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spelling pubmed-58719482018-03-29 Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics Rykhus, Ryan D. Shepard, Zachary V. Young, Alix Frisby, Hadley Calder, Kailee A. Coon, Collin M. Falk, Justin A. McAndrews, Sydney R. Turner, Aspen Chang, Christina Michelsohn, Johanna Petch, Raegan Dieker, Sarah M. Markworth, Benjamin H. Alamo-Perez, Kevin Hosack, Aaron J. Berg, Jacob M. Schmidt, Christian Storsberg, Joachim Brown, Mark A. Diseases Communication 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. MDPI 02017-12-22 /pmc/articles/PMC5871948/ /pubmed/29271878 http://dx.doi.org/10.3390/diseases6010002 Text en © 2017 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Communication
Rykhus, Ryan D.
Shepard, Zachary V.
Young, Alix
Frisby, Hadley
Calder, Kailee A.
Coon, Collin M.
Falk, Justin A.
McAndrews, Sydney R.
Turner, Aspen
Chang, Christina
Michelsohn, Johanna
Petch, Raegan
Dieker, Sarah M.
Markworth, Benjamin H.
Alamo-Perez, Kevin
Hosack, Aaron J.
Berg, Jacob M.
Schmidt, Christian
Storsberg, Joachim
Brown, Mark A.
Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics
title Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics
title_full Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics
title_fullStr Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics
title_full_unstemmed Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics
title_short Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics
title_sort facilitating a more efficient commercial review process for pediatric drugs and biologics
topic Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5871948/
https://www.ncbi.nlm.nih.gov/pubmed/29271878
http://dx.doi.org/10.3390/diseases6010002
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