Regulatory Framework for Drug-Device Combination Products in the United States, Europe, and Korea.

Combination products (CPs) combine two or more product types such as drugs, devices, and/or biological products for increased safety and clinical effectiveness. The emergence of innovative CPs poses new challenges for regulatory agencies in assigning jurisdiction for premarket review and oversight. In US, the 1990 Safe Medical Devices Act defines and provides classification criteria for CPs, and the US government has developed a regulatory process through multiple acts, including the 21st Century Cures Act of 2016.

Anhydrous Alum Inhibits α-MSH-Induced Melanogenesis by Down-Regulating MITF via Dual Modulation of CREB and ERK.

Melanogenesis, the intricate process of melanin synthesis, is central to skin pigmentation and photoprotection and is regulated by various signaling pathways and transcription factors. To develop potential skin-whitening agents, we used B16F1 melanoma cells to investigate the inhibitory effects of anhydrous alum on melanogenesis and its underlying molecular mechanisms. Anhydrous alum (KAl(SO)) with high purity (>99%), which is generated through the heat-treatment of hydrated alum (KAl(SO)·12HO) at 400 °C, potentiates a significant reduction in melanin content without cytotoxicity.

Recent Advances in Biosensor Technologies for Point-of-Care Urinalysis.

Human urine samples are non-invasive, readily available, and contain several components that can provide useful indicators of the health status of patients. Hence, urine is a desirable and important template to aid in the diagnosis of common clinical conditions. Conventional methods such as dipstick tests, urine culture, and urine microscopy are commonly used for urinalysis.

Ultra-fast and recyclable DNA biosensor for point-of-care detection of SARS-CoV-2 (COVID-19).

Rapid diagnosis and case isolation are pivotal to controlling the current pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In this study, a label-free DNA capacitive biosensor for the detection of SARS-CoV-2 that demonstrates real-time, low-cost, and high-throughput screening of nucleic acid samples is presented. Our novel biosensor composed of the interdigitated platinum/titanium electrodes on the glass substrate can detect the hybridization of analyte DNA with probe DNA.

Structural requirements for the neuroprotective effects of aspirin analogues against N-methyl-D-aspartate and zinc ion neurotoxicity.

In order to elucidate the structural requirements for the dual neuroprotective activity of aspirin against N-methyl-D-aspartate (NMDA) and zinc ion neurotoxicity, various aspirin analogues and derivatives, modified at the carboxylic group, the acetyl group, and the chain length between the carboxylic acid moiety and phenyl ring, were synthesized. Replacement of the carboxylic acid group with alkyl groups (compounds 2c and 2d) resulted in a dramatic increase in neuroprotective activity against NMDA neurotoxicity, while reduction of the carboxylic acid group to the alcohol (compound 2g) completely abolished this activity. In contrast to NMDA neurotoxicity, compounds that are devoid of the carboxylic acid group did not show any activity against zinc ion neurotoxicity.

Hydrogen peroxide-induced cell death in cultured Aplysia sensory neurons.

Widespread neuronal cell death occurs during normal development and as a result of pathological conditions in the nervous system of many organisms. In this study, we investigated the cytotoxicity induced by H(2)O(2) in Aplysia mechanosensory neurons, which serve as a useful model in the study of learning and memory. Treatment with hydrogen peroxide (10(-2)-10 mM) for 3 h produced a nuclear DNA breakage in Aplysia sensory neurons, as revealed by TdT-mediated dUTP nick end labeling (TUNEL) staining, in a dose-dependent manner.