New Drugs Regulatory Program Modernization: Vision, Strategic Objectives, and Impact
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ANALYTICAL REPORT
New Drugs Regulatory Program Modernization: Vision, Strategic Objectives, and Impact Kevin Bugin, MS, PhDc, RAC1 · Janet Woodcock, MD1 · Peter Stein, MD1 · Khushboo Sharma, MBA, RAC1 · Yonatan Tyberg, MHIA1 Received: 28 August 2020 / Accepted: 9 October 2020 © The Drug Information Association, Inc 2020
Abstract In response to a rapid increase in drug development activity during the past two decades, the Food and Drug Administration’s Center for Drug Evaluation and Research launched a multi-year effort in 2017 to modernize the program by which new drug products are regulated, known as the New Drugs Regulatory Program. Following a detailed analysis of FDA activities in new drug development, premarket review, and postmarket monitoring, the Office of New Drugs was restructured to therapeutically align its clinical offices and to add new cross-functional offices for regulatory support. An interdisciplinary review process for new drug and biologics applications was rolled out to reduce redundancy and produce review documents that effectively communicate the scientific basis for the regulatory decision. The investigational new drug (IND) review process was also streamlined. During the next 2 years, the modernization initiative will seek to attract and retain new scientific and regulatory staff, improve postmarket safety monitoring, increase efficiency of drug review via technology-enabled workflows, and standardize the capture and use of scientific data to inform future regulatory decisions. The modernization effort will position the New Drugs Regulatory Program to continually improve and adapt to innovations in science, technology, and drug development. Keywords Reorganization · Program improvements · Modernizing FDA · Drug development
Introduction The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) has a mission to protect and promote the health of the American people by ensuring that drugs are safe and effective for their intended use, meet established quality standards, and are available to patients [1]. The New Drugs Regulatory Program (NDRP) consists of review staff from several different CDER offices, including the Office of New Drugs (OND), the Office of Translational Science (OTS), the Office of Pharmaceutical Quality (OPQ), and the Office of Surveillance and
This paper is based on a presentation of the same name given at the DIA Annual Virtual Meeting, June 2020. * Kevin Bugin [email protected] 1
Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
Epidemiology (OSE). As part of this program, these review staff have the responsibility to provide regulatory oversight for investigational studies during drug development, make decisions regarding marketing approval and labeling of new drugs and biological therapeutics, and provide guidance to industry on a variety of clinical, scientific, and regulatory matters. In 2017, CDER began a multi-year initiative to mod
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