Impact of delivery rate on the acute response to intravenous nicotine: A human laboratory study with implications for regulatoryscience. Faster delivery rate enhances the abuse potential of drugs of abuse, yet systematic studies on the impact of delivery rate on the acute effects of nicotine in humans are lacking. Using an intravenous (IV) nicotine infusion procedure that allows precise control effects and have timely implications for developing novel therapeutics for nicotine dependence, as well as for tobacco regulatoryscience.
Establishing a RegulatoryScience System for Supervising the Application of Artificial Intelligence for Traditional Chinese Medicine: A Methodological Framework. In this study, we reported a methodological framework for the development of a guideline for establishing a regulatoryscience system for supervising the application of artificial intelligence for traditional Chinese medicine (TCM
Behavior change, health, and health disparities 2022: Innovations in tobacco control and regulatoryscience to decrease cigarette smoking. This Special Issue of Preventive Medicine (PM) is the 9th in a series on behavior change, health, and health disparities. This topic is critically important to improving population health. Unhealthy lifestyles including substance misuse, unhealthy food choices the introduction of new tobacco products into the marketplace like electronic nicotine delivery systems (ENDS) demands attention, it is essential that we remain focused on the enormous challenges involved in eliminating cigarette smoking. This Special Issue examines innovations in tobacco control and regulatoryscience aimed towards reducing cigarette smoking. Discussion of new tobacco products is largely
RegulatoryScience, and How Device Regulation Will Shape Our Future. Pediatric medical device approvals lag behind adult approvals. Historically, medical devices have rarely been designed specifically for children, but use in children has most often borrowed from adult or general use applications. While a variety of social, economic, and clinical factors have contributed to this phenomenon
A review of tobacco regulatoryscience research on vulnerable populations. In 2013 the U.S. Food and Drug Administration and National Institutes of Health established fourteen Tobacco Centers of RegulatoryScience (TCORS) to advance scientific knowledge relevant to conducting evidence-based tobacco regulation. This report reviews TCORS-funded research with adult vulnerable populations
ISPOR, the FDA, and the Evolving RegulatoryScience of Medical Device Products. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a key venue for members from private industry, government, and academia to collaborate and share advances in regulatory, clinical, and reimbursement science for drugs, devices, and diagnostics. In parallel, the US Food and Drug medical technologies. With a focus on regulatoryscience, the MDIC has been assessing how to apply real-world evidence (RWE) regulatoryscience to medical devices. A key goal of this project is to review the history of RWE regulatoryscience, define terms, and explain why and how RWE is being considered across the total product life cycle, including regulatory assessment. Unique considerations of real
Preclinical Development of Cell-Based Products: a European RegulatoryScience Perspective This article describes preclinical development of cell-based medicinal products for European markets and discusses European regulatory mechanisms open to developers to aid successful product development. Cell-based medicinal products are diverse, including cells that are autologous or allogeneic, have been
Advancing RegulatoryScience With Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories Protecting and promoting public health is the mission of the U.S. Food and Drug Administration (FDA). FDA's Center for Devices and Radiological Health (CDRH), which regulates medical devices marketed in the U.S., envisions itself as the world's leader in medical device innovation and regulatoryscience-the development of new methods, standards, and approaches to assess the safety, efficacy, quality, and performance of medical devices. Traditionally, bench testing, animal studies, and clinical trials have been the main sources of evidence for getting medical devices on the market in the U.S. In recent years, however, computational modeling has become
Cigarette Management System: An operating procedures guide to obtaining and managing investigational tobacco products for regulatoryscience research Investigational tobacco products, specifically variable nicotine content research cigarettes (SPECTRUM), are available through the National Institute of Drug Abuse Drug Supply Program. Randomized controlled trials using research cigarettes are intended to support tobacco regulatoryscience research. The current paper provides an in-depth look into managing research cigarettes for two multi-site clinical trials and the design of a computer-based Cigarette Management System (CMS). The paper provides guidance intended for any investigator using similar products on the operating procedures under Good Clinical Practice standards and describes
Regulating Ionizing Radiation Based on Metrics for Evaluation of RegulatoryScience Claims This article attempts to reconcile differences within the relevant scientific community on the effect of exposure to low levels of ionizing radiation notably the applicability of linear nonthreshold (LNT) process at exposures below a certain limit. This article applies an updated version of Metrics for Evaluation of RegulatoryScience Claims (MERSC) derived form Best Available RegulatoryScience (BARS) to the arguments provided by the proponents and opponents of LNT. Based on BARS/MERSC, 3 categories of effects of exposure to ionizing radiation are identified. One category (designated as S) consists of reproducible and undisputed adverse effects. A second category (designated as U) consists of areas
Proceedings of the Food and Drug Administration's public workshop on new red blood cell product regulatoryscience 2016. The US Food and Drug Administration (FDA) held a workshop on red blood cell (RBC) product regulatoryscience on October 6 and 7, 2016, at the Natcher Conference Center on the National Institutes of Health (NIH) Campus in Bethesda, Maryland. The workshop was supported
Case definitions for inclusion and analysis of endpoints in clinical trials for NASH through the lens of regulatoryscience. Nonalcoholic steatohepatitis (NASH) is an important cause of liver-related morbidity and mortality. There are no approved therapies, and the results of clinical trials have been difficult to compare due to inconsistent definitions of relevant disease parameters in patients development for NASH by developing potential solutions to barriers to development. The Case Definitions Working Group was established by The Liver Forum to evaluate the validity of case definitions for populations to be included in clinical trials for NASH from a regulatoryscience perspective. Based on such analyses, specific recommendations are provided noting the strengths and weaknesses of the case
The life cycles of six multi-center adaptive clinical trials focused on neurological emergencies developed for the Advancing RegulatoryScience initiative of the National Institutes of Health and US Food and Drug Administration: Case studies from the Adap Clinical trials are complicated, expensive, time-consuming, and frequently do not lead to discoveries that improve the health of patients
Advancing Public Health Using RegulatoryScience to Enhance Development and Regulation of Medical Products: Food and Drug Administration Research at the Center for Biologics Evaluation and Research Center for Biologics Evaluation and Research enhances and supports regulatory decision-making and policy development. This work contributes to our regulatory mission, advances medical product
Mentoring for Success in Tobacco RegulatoryScience: A Qualitative Study Our study explores the experiences of early career and senior scientists regarding mentorship and career trajectories in tobacco regulatoryscience (TRS). We conducted 22 phone interviews with early career and senior tobacco regulatory scientists from July 2015 to January 2016. All interviews were conducted using
Translating New Science Into the Drug Review Process: The US FDA’s Division of Applied RegulatoryScience In 2011, the US Food and drug Administration (FDA) developed a strategic plan for regulatoryscience that focuses on developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. In line with this, the Division of Applied RegulatoryScience was created to move new science into the Center for Drug Evaluation and Research (CDER) review process and close the gap between scientific innovation and drug review. The Division, located in the Office of Clinical Pharmacology, is unique in that it performs mission-critical applied research and review across the translational research spectrum including in vitro and in vivo laboratory
Duchenne RegulatoryScience Consortium Meeting on Disease Progression Modeling for Duchenne Muscular Dystrophy The Duchenne RegulatoryScience Consortium (D-RSC) was established to develop tools to accelerate drug development for DMD. The resulting tools are anticipated to meet validity requirements outlined by qualification/endorsement pathways at both the U.S. Food and Drug Administration
Collaboration in RegulatoryScience to Facilitate Therapeutic Development for Neonates Historically, neonatal therapeutic interventions were derived from adult therapeutics, and tragedies resulting from this approach have demonstrated differences in the pathophysiologic and developmental processes between neonates and older patients. Over the past 3 decades, researchers and collaborative
Contribution to regulatoryscience and a next challenge of the Japanese Environmental Mutagen Society (JEMS) Many members of The Japanese Environmental Mutagen Society (JEMS) have significantly contributed to guidelines on chemical genotoxicity. The guidelines have been useful for the hazard identification and risk assessment of genotoxic chemicals. However, risk assessors and developers of drugs