Evaluating mobile harm reduction services for youth and young adults.

The adolescent and young adult (AYA) population has experienced an increase in both emergency room visits and deaths related to substance use. However, AYA are less likely to engage in existing addiction treatment infrastructure. A youth-specific mobile harm reduction program has the potential to reduce substance-related morbidity and mortality including infections, overdose, and death.

Evaluation of FDA Labeling Changes Related to PREA Safety-Waivers.

Purpose: The Pediatric Research Equity Act (PREA) gives the US Food and Drug Administration (FDA) authority to require pediatric studies for drug and biologics products under certain circumstances and to waive this requirement in some, or all, pediatric ages. When studies are waived for safety, PREA stipulates the safety issue must be described in labeling. This study assessed the rate of including waiver-related safety information in labeling.

Considerations and Challenges in the Remdesivir COVID-19 Pediatric Development Program.

The US Food and Drug Administration is committed to the development of effective antiviral regimens for pediatric patients with coronavirus disease 2019 (COVID-19), including infants and neonates. On April 25, 2022, the approved indication of remdesivir (RDV) was expanded to include pediatric patients 28 days and older and weighing at least 3 kg with positive results of direct severe acute respiratory syndrome coronavirus 2 viral testing, who are: Hospitalized, or Not hospitalized and have mild to moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death. Given the similar course of COVID-19 in adults and pediatric patients, the approval of RDV for use in pediatric patients is supported by the safety and efficacy data from adequate and well-controlled phase 3 trials in adults and adolescents; and by the safety and pharmacokinetic data from a single-arm, open-label, phase 2/3 pediatric clinical trial of 53 pediatric patients at least 28 days of age and weighing at least 3 kg with confirmed severe acute respiratory syndrome coronavirus 2 infection and mild, moderate, or severe COVID-19.

Reciprocal effects of maternal and child internalizing symptoms before and after a natural disaster.

After natural disasters, mothers and children are vulnerable to internalizing symptoms, such as depression and anxiety, and levels of mothers' and children's symptoms are significantly associated. However, the disaster literature has rarely examined reciprocal effects within families. The present study capitalizes on the occurrence of Hurricane Sandy during the course of an ongoing longitudinal study to address this gap.