Author Interviews / 09.07.2021

MedicalResearch.com Interview with: David Strauss, MD, PhD Director, Division of Applied Regulatory Science David Keire, PhD Director, Office of Testing and Research U.S. Food and Drug Administration Center for Drug Evaluation and Research MedicalResearch.com: What is the background for this study? Response: In 2019, the US Food and Drug Administration (FDA) received a citizen petition indicating that ranitidine, a widely used prescription and over-the-counter drug, contained the probable human carcinogen N-nitrosodimethylamine (NDMA). In addition, the petitioner proposed that ranitidine could convert to NDMA in humans; however, this was based on a small clinical study with limitations and an in vitro study that included high level of supplemental nitrite. In response, the FDA immediately alerted the public and began an investigation. The FDA’s initial research found that the procedures previously used to quantify NDMA were not appropriate for assessing its presence in ranitidine, owing to the use of high temperatures that could convert ranitidine to NDMA during that analysis. New lower-temperature analytical methods found that the amounts of NDMA contained in ranitidine products were 3,000-fold lower than those reported in the citizen petition; however, these lower amounts of NDMA were still above the FDA-acceptable level and could increase over time, prompting the FDA to request the market withdrawal of ranitidine products. The FDA noted, however, that if ranitidine products could be manufactured to control NDMA amounts, they could be allowed back on the market—but additional information would first be needed to understand whether NDMA could form in vivo from ranitidine in humans. (more…)
Author Interviews, FDA, JAMA, Medical Imaging / 04.12.2018

MedicalResearch.com Interview with: Aldo Badano, Ph.D. Deputy Director, Division of Imaging, Diagnostics, and Software Reliability Office of Science and Engineering Laboratories Center for Devices and Radiological Health Silver Spring, MD 20993 Aldo Badano, Ph.D. Deputy Director, Division of Imaging, Diagnostics, and Software Reliability Office of Science and Engineering Laboratories Center for Devices and Radiological Health Silver Spring, MD 20993 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Expensive and lengthy clinical trials can delay regulatory evaluation of innovative technologies, affecting patient access to high-quality medical products. Although computational modeling is increasingly being used in product development, it is rarely at the center of regulatory applications. Within this context, the VICTRE project attempted to replicate a previously conducted imaging clinical trial using only computational models. The VICTRE trial involved no human subjects and no clinicians. All trial steps were conducted in silico. The fundamental question the article addresses is whether in silico imaging trials are at a mature development stage to play a significant role in the regulatory evaluation of new medical imaging systems. The VICTRE trial consisted of in silico imaging of 2986 virtual patients comparing digital mammography (DM) and digital breast tomosynthesis (DBT) systems. The improved lesion detection performance favoring DBT for all breast sizes and lesion types was consistent with results from a comparative trial using human patients and radiologists. (more…)