The Utilization of the Accelerated Approval Pathway in Oncology: A Case Study of Pembrolizumab.

The accelerated approval (AA) pathway was established by the United States Food and Drug Administration (FDA) to provide earlier access to therapies for patients with serious medical conditions and unmet medical needs. Since its inception, the AA pathway has been used for novel treatments across different therapeutic areas, but most prominently in oncology, including the immune checkpoint inhibitor class. This review article describes the history of regulatory approvals for pembrolizumab, an immunotherapy agent targeting programmed death receptor-1 (PD-1), and use of the AA pathway and the corresponding regulatory decisions made by the FDA.

Heat Tolerance Testing and the Return to Duty Decision: A Two-Year Case Cohort Analysis.

Background: Among individuals with prior exertional heat illness (EHI), heat tolerance testing (HTT) may inform risk and return to duty/activity. However, little is known about HTT's predictive validity, particularly for EHI recurrence. Our project sought to demonstrate the predictive validity of HTT in EHI recurrence and HTT's utility as a diagnostic tool in exertional heat stroke (EHS).

Challenges of Agitation in Dementia: A Plea for Early Discussion.

Behavioral and psychological symptoms of dementia (BPSD) occur frequently among people with dementia and are known precipitants for placement in care facilities. Despite the social, financial, and psychological impact on dementia care, education and discussions on BPSD have not been routinely included in advance care planning (ACP). As a result, families can face great challenges in making complex medical decisions when their loved ones are admitted to the geriatric psychiatric inpatient unit with refractory BPSD.

Clinical Trial Diversity in Oncology: FDA Takes Action with Post-Marketing Requirements or Commitments.

In recent years, there has been a renewed focus on promoting the inclusion of patients from racial and ethnic minority groups in oncology clinical trials. FDA Oncology has long pointed to the underrepresentation of racial minorities in registration trials leading to approval. US FDA's Guidance on diversity discusses how diversity could be handled within clinical trials, giving recommendations on broadening eligibility criteria, inclusive trial practices, and alternative trial designs.

Point-of-care Ultrasound to Distinguish Retinal Detachment and Ruptured Arterial Microaneurysm.

Case Presentation: We present the case of an older male with point-of-care-ultrasound (POCUS) imaging consistent with retinal detachment who was instead found by ophthalmology to have a ruptured arterial microaneurysm with vitreous and preretinal hemorrhage. The patient later had complete resolution of his symptoms. We discuss this retinal detachment "mimic.