FDA Postmarket Safety Studies Face Widespread Delays Across Hundreds of Products

By David Hilzenrath · KFF Health News · 2026-09-18

A KFF Health News investigation reveals that nearly 600 required follow-up studies for drugs and medical devices are currently behind schedule. While the FDA increasingly approves treatments based on limited initial data to accelerate patient access, manufacturers frequently fail

A KFF Health News investigation reveals that nearly 600 required follow-up studies for drugs and medical devices are currently behind schedule. While the FDA increasingly approves treatments based on limited initial data to accelerate patient access, manufacturers frequently fail