Regulatory watch: The target product profile as a tool for regulatory communication: advantageous but underused

Medication nonadherence, a major problem in cardiovascular disease (CVD), contributes yearly to approximately 125,000 preventable deaths, which is partly attributable to only about one-half of CVD patients consistently taking prescribed life-saving medications. Current interest has focused on how la …

We have investigated the potential for contrast-enhanced near-infrared fluorescence imaging of tissue on a mobile phone platform. Charge-coupled device- and phone-based cameras were used to image molded and three-dimensional-printed tissue phantoms, and an ex vivo animal model. Quantitative and qual …

The performance of a classifier is largely dependent on the size and representativeness of data used for its training. In circumstances where accumulation and/or labeling of training samples is difficult or expensive, such as medical applications, data augmentation can potentially be used to allevia …

Wide-angle parabolic models are commonly used in geophysics and underwater acoustics but have seen little application in medical ultrasound. Here, a wide-angle model for continuous-wave high-intensity ultrasound beams is derived, which approximates the diffraction process more accurately than the co …

Lack of Effects of Toll-Like Receptor 4 Antagonists on the Reinforcing Effects of Cocaine and Remifentanil

As technologies evolve, and diagnostics move from detection of single biomarkers toward complex signatures, an increase in the clinical use and regulatory submission of complex signatures is anticipated. However, to date, no complex signatures have been approved as companion diagnostics. In this art …

Acid hydrolyzed vegetable protein (aHVP) is used for flavoring a wide variety of foods and also in the production of nonfermented soy sauce. During the production of aHVP, chloropropanols including 3-monochloropropane-1,2-diol (3-MCPD) and 1,3 dichloropropane-2-ol (1,3-DCP) can be formed through the …

Both regulatory science and clinical practice rely on data-driven approaches to guide decision making; however, additional factors are also important in clinical practice that do not impact regulatory decision making, and these considerations may result in heterogeneity in clinical uptake of pharmac …

The expanded access program is viewed as a success from FDA's perspective based on the large number of applications processed and allowed to proceed each year. However, the actual number of patients and their health care providers that desire drug treatments available under expanded access is not kn …

The enrollment of adolescents with cancer in clinical trials is much lower than that of younger pediatric patients. For adolescents with "adult-type" cancers, lack of access to relevant trials is cited as one of the reasons for this discrepancy. Adolescents are generally not eligible for enrollment …

Safe and effective neuroprosthetic systems are of great interest to both DARPA and CDRH, due to their innovative nature and their potential to aid severely disabled populations. By expanding what is possible in human-device interaction, these devices introduce new potential benefits and risks. There …

Pharmaceuticals approved in the United States are largely not known human carcinogens. However, cancer signals associated with pharmaceuticals may be hypothesized or arise after product approval. There are many study designs that can be used to evaluate cancer as an outcome in the postapproval setti …

Induced pluripotent stem cell-derived cardiomyocytes (iPSC-CM) hold promise for assessment of drug-induced arrhythmias and are being considered for use under the comprehensive in vitro proarrhythmia assay (CiPA). We studied the effects of 26 drugs and 3 drug combinations on 2 commercially available …

Data systems and record linkage: considerations for pharmacoepidemiologic studies examining cancer risk

Metallic medical devices such as intravascular stents can undergo fretting damage in vivo that might increase their susceptibility to pitting corrosion. As a result, the US Food and Drug Administration has recommended that such devices be evaluated for corrosion resistance after the devices have bee …

DAT Conformation Does Not Predict the Ability of Atypical Dopamine Uptake Inhibitors to Substitute for Cocaine

Medical Devices and Adolescents: Points to Consider

Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account these systems' perspective. In this article, we describe the current development of medical device …

Scores produced by statistical classifiers in many clinical decision support systems and other medical diagnostic devices are generally on an arbitrary scale, so the clinical meaning of these scores is unclear. Calibration of classifier scores to a meaningful scale such as the probability of disease …

In the United States, all food products have to be regulated to inform the consumers of the ingredients contained within. Some ingredients are not included on the label and yet are still found in the products. Presented is a Raman imaging technique for rapid, nondestructive, and spatially relevant l …

Hemoglobin-based oxygen carriers (HBOCs) are being developed as oxygen and plasma volume-expanding therapeutics though their potential to promote oxidative tissue injury has raised safety concerns. Using a guinea pig exchange transfusion model, we examined the effects of polymerized bovine hemoglobi …

(-)-Trans-Δ9-Tetrahydrocannabinol-Like Discriminative-Stimulus Effects of Gabapentin in Cannabis Users

In this article, we describe the role of "clinical scenario" information to assure the safety of interoperable systems, as well as the system's ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, work …

The method developed allows for AEs to be found in clinical trial databases and evaluated using software programs that are readily available to clinical researchers.

The understanding of interactions between electromagnetic (EM) fields and nerves are crucial in contexts ranging from therapeutic neurostimulation to low frequency EM exposure safety. To properly consider the impact of in vivo induced field inhomogeneity on non-linear neuronal dynamics, coupled EM-n …

An intricate network of a variety of nerves is embedded within the complex anatomy of the human body. Although nerves are shielded from unwanted excitation, they can still be stimulated by external electromagnetic sources that induce strongly non-uniform field distributions. Current exposure safety …