Avoiding 510(k) Submission Gaps: Practical Human Factors Engineering Strategies to Reduce Rework, FDA Questions, and Project Delays

Early human factors engineering (HFE) decisions directly influence the strength, defensibility, and efficiency of Food and Drug Administration (FDA) 510(k) submissions. Yet, common gaps such as inc...

Preventing Cisplatin-Induced Ototoxicity in Pediatrics: What You Need to Know to Improve Patient Outcomes

Overview  Cisplatin is a commonly used chemotherapeutic agent for the treatment of certain childhood cancers, including germ cell tumors, hepatoblastoma, medulloblastoma, neuroblastoma, and osteosa...