Day: July 10, 2025

Antibacterial therapies targeting serious infections in patients with limited or no therapeutic options are hard to develop for scientific, logistical, and financial reasons. FDA’s latest guidance describes the FDA’s expectations for developers of antibiotics for patients with an unmet medical need for a serious bacterial infection. The guidance articulates a science- and risk-based framework for … Read more

Cyber threats can present a direct risk to patient lives. The FDA’s updated 2025 guidance on cybersecurity in medical devices emphasizes, with templates and examples, the importance of cybersecurity considerations from the first line of code. The new guidance adds on to previous guidances to outline the FDA’s expectations from what manufacturers must do to … Read more