BACKGROUND: Human protein kinases play important roles in cancers, are highly co-regulated by kinase families rather than a single kinase, and complementarily regulate signaling pathways. Even though there are > 100,000 protein kinase inhibitors, onl...
BACKGROUND: The US Food and Drug Administration (FDA) collects and retains several data sets on post-market drugs and associated adverse events (AEs). The FDA Adverse Event Reporting System (FAERS) contains millions of AE reports submitted by the pub...
Artificial intelligence (AI) is becoming more widespread within radiology. Capabilities that AI algorithms currently provide include detection, segmentation, classification, and quantification of pathological findings. Artificial intelligence softwar...
In a drug formulation (DFM), the major components by mass are not Active Pharmaceutical Ingredient (API) but rather Drug Inactive Ingredients (DIGs). DIGs can reach much higher concentrations than that achieved by API, which raises great concerns abo...
AIM: To examine the current landscape of US Food and Drug Administration (FDA)-approved artificial intelligence (AI) medical imaging devices and identify trends in clinical validation strategy.
Therapeutic innovation & regulatory science
May 1, 2023
The use of Bayesian statistics to support regulatory evaluation of medical devices began in the late 1990s. We review the literature, focusing on recent developments of Bayesian methods, including hierarchical modeling of studies and subgroups, borro...
Although there has been a resurgence of interest in low field magnetic resonance imaging (MRI) systems in recent years, low field MRI is not a new concept. FDA has a long history of evaluating the safety and effectiveness of MRI systems encompassing ...
INTRODUCTION: Time- and resource-demanding activities related to processing individual case safety reports (ICSRs) include manual procedures to evaluate individual causality with the final goal of dismissing false-positive safety signals. Eminent exp...
IMPORTANCE: The marketing of health care devices enabled for use with artificial intelligence (AI) or machine learning (ML) is regulated in the US by the US Food and Drug Administration (FDA), which is responsible for approving and regulating medical...