New science, drug regulation, and emergent public health issues: The work of FDA’s division of applied regulatory science

Kimberly Chiu; Rebecca Racz; Keith Burkhart; Jeffry Florian; Kevin Ford; M. Iveth Garcia; Robert M. Geiger; Kristina E. Howard; Paula L. Hyland; Omnia A. Ismaiel; Naomi L. Kruhlak; Zhihua Li; Murali K. Matta; Kristin W. Prentice; Kristin W. Prentice; Aanchal Shah; Aanchal Shah; Lidiya Stavitskaya; Donna A. Volpe; James L. Weaver; Wendy W. Wu; Rodney Rouse; David G. Strauss

doi:10.3389/fmed.2022.1109541

Frontiers in Medicine (Jan 2023)

New science, drug regulation, and emergent public health issues: The work of FDA’s division of applied regulatory science

Kimberly Chiu,
Rebecca Racz,
Keith Burkhart,
Jeffry Florian,
Kevin Ford,
M. Iveth Garcia,
Robert M. Geiger,
Kristina E. Howard,
Paula L. Hyland,
Omnia A. Ismaiel,
Naomi L. Kruhlak,
Zhihua Li,
Murali K. Matta,
Kristin W. Prentice,
Kristin W. Prentice,
Aanchal Shah,
Aanchal Shah,
Lidiya Stavitskaya,
Donna A. Volpe,
James L. Weaver,
Wendy W. Wu,
Rodney Rouse,
David G. Strauss

Affiliations

Kimberly Chiu: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Rebecca Racz: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Keith Burkhart: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Jeffry Florian: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Kevin Ford: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
M. Iveth Garcia: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Robert M. Geiger: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Kristina E. Howard: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Paula L. Hyland: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Omnia A. Ismaiel: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Naomi L. Kruhlak: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Zhihua Li: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Murali K. Matta: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Kristin W. Prentice: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Kristin W. Prentice: Booz Allen Hamilton, McLean, VA, United States
Aanchal Shah: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Aanchal Shah: Booz Allen Hamilton, McLean, VA, United States
Lidiya Stavitskaya: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Donna A. Volpe: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
James L. Weaver: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Wendy W. Wu: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
Rodney Rouse: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States
David G. Strauss: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States

DOI: https://doi.org/10.3389/fmed.2022.1109541
Journal volume & issue: Vol. 9

Abstract

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The U.S. Food and Drug Administration (FDA) Division of Applied Regulatory Science (DARS) moves new science into the drug review process and addresses emergent regulatory and public health questions for the Agency. By forming interdisciplinary teams, DARS conducts mission-critical research to provide answers to scientific questions and solutions to regulatory challenges. Staffed by experts across the translational research spectrum, DARS forms synergies by pulling together scientists and experts from diverse backgrounds to collaborate in tackling some of the most complex challenges facing FDA. This includes (but is not limited to) assessing the systemic absorption of sunscreens, evaluating whether certain drugs can convert to carcinogens in people, studying drug interactions with opioids, optimizing opioid antagonist dosing in community settings, removing barriers to biosimilar and generic drug development, and advancing therapeutic development for rare diseases. FDA tasks DARS with wide ranging issues that encompass regulatory science; DARS, in turn, helps the Agency solve these challenges. The impact of DARS research is felt by patients, the pharmaceutical industry, and fellow regulators. This article reviews applied research projects and initiatives led by DARS and conducts a deeper dive into select examples illustrating the impactful work of the Division.

Published in Frontiers in Medicine

ISSN: 2296-858X (Online)
Publisher: Frontiers Media S.A.
Country of publisher: Switzerland
LCC subjects: Medicine: Medicine (General)
Website: http://www.frontiersin.org/journals/medicine

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