Regulator says that warnings about the safety and effectiveness of testosterone replacement therapy should be removed from labels.
FDA
The guidance demonstrates how therapy sponsors can build on existing science to reduce redundant testing and accelerate treatments.
A leadership vacuum at the FDA hits crisis mode as the Trump administration scrambles to replace departing senior officials and restore stability.
Multi-agency vaccine safety review prompts pushback from former CDC officials and researchers for revisiting issues already extensively studied.
Makary stepped down amid a widening rift over tobacco regulation and a series of contentious decisions that reshaped the FDA’s internal politics.
While the initiative was greeted with cheers of support at the MAHA Institute summit, many behavioral health specialists warned the effort risks stigmatizing care and reducing treatment options.
The pilot program will run through the end of fiscal year 2026, with additional assessments planned across multiple inspectorates.
The regulator’s report also signaled that tighter oversight of the infant nutrition industry isn’t far behind.