Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Chiu K

PROVIDER: S-EPMC9893027 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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

Chiu Kimberly K Racz Rebecca R Burkhart Keith K Florian Jeffry J Ford Kevin K Iveth Garcia M M Geiger Robert M RM Howard Kristina E KE Hyland Paula L PL Ismaiel Omnia A OA Kruhlak Naomi L NL Li Zhihua Z Matta Murali K MK Prentice Kristin W KW Shah Aanchal A Stavitskaya Lidiya L Volpe Donna A DA Weaver James L JL Wu Wendy W WW Rouse Rodney R Strauss David G DG

Frontiers in medicine 20230119

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 ...[more]

PMID: 36743666

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Project description:The field of public health includes a wide scope of activities and professional disciplines, ranging from sanitation, health protection, epidemiology, environmental health, financing, health promotion, including supervision, or the provision of clinical care. Each of these disciplines works in systems that face ethical dilemmas, making it important that public health workers have motivation to understand and practice within the ethical guidelines of their profession, thus making ethics an important component of training and practice. The dangers of ethical lapses are overwhelmingly apparent in the case of the Eugenics movement of the early 20th century which metamorphosed from forced sterilizations in many liberal democratic countries into mass murder of physically and mentally handicapped children and adults in Nazi Germany. Between 1939 and 1941, 180 thousand psychiatric patients along with an equivalent number of handicapped children and adults were killed in an organized extermination program in Germany by lethal gassing. This method was then applied to the industrialized murder or Holocaust of six million Jews and millions of other “untermenschen” (sub human) in the greatest genocide in human history. Shortly after World War II ended the Nuremberg Trials of Nazi war criminals were conducted including medical doctors, and some were executed for crimes against humanity. This was followed by the 1948 United Nations Declaration on Human Rights and by the World Medical Association’s Helsinki Declaration. Both are widely accepted as cornerstone documents—the latter specifically governing ethical standards related to human experimentation—and are revised regularly since being issued in 1964. But genocide has not disappeared, nor has unscrupulous experimentation such as the Tuskegee experiment on black Americans infected with syphilis and left untreated even after the availability of a cure, penicillin. Ethical standards are now required by “Helsinki Committees”—ethical review boards—in most medical facilities worldwide. Ethical frameworks have evolved in part due to bitter experience of ethical failures later recognized and affecting public health standards of practice. Future generations of public health leaders and staff will face many ethical issues such as mandatory immunization of health workers and school children, and assisted death of terminally ill patients.

Dataset Information

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

Publications

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

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