A federal review of FDA records and enforcement actions found that postmarket studies required as conditions of approval are frequently delayed or lag far behind enrollment plans. The example highlighted a delayed safety study tied to Tavneos, where FDA records cited limited initial safety data and approval depended on long-term follow-up. According to the article, as of last fall only 21 of 300 planned patients had been enrolled in the Tavneos postmarket study, with the FDA repeating concerns in an April letter and related regulatory postings. The FDA also identified dozens of liver injury cases “possibly” or “probably” causally associated with the therapy—events the postmarket study was intended to further evaluate. A KFF Health News analysis cited hundreds of delayed postmarket studies across drugs and devices, sometimes extending more than a decade or leaving sponsors still developing study plans long after approval. The piece also includes criticism from UCSF cardiologist Sanket Dhruva, who said postmarket requirements have “often proven toothless,” raising renewed questions about patient risk transparency during real-world use.