A KFF Health News analysis highlights how FDA-ordered postmarket studies for drugs and devices frequently lag, leaving limited real-world safety answers even after regulatory approvals. The review centers on the rare autoimmune medicine Tavneos, which was approved in 2021 with a requirement for an additional years-long safety study; as of last fall, only 21 of a planned 300 patients had been enrolled. The FDA records cited in the report show delayed enrollment and other follow-through problems across hundreds of postmarket studies, with some delayed by more than a decade. In Tavneos’ case, the FDA has also identified dozens of cases of liver damage that are possibly or probably causally associated with the drug—an adverse outcome the postmarket study was meant to evaluate. The piece cites expert criticism that postmarket study requirements can become “toothless,” while also acknowledging the FDA’s balancing act: faster approvals can benefit patients with limited options, but long-term risk clarity depends on completion of these studies. For biotech and med-tech companies, the report is a regulatory risk reminder: even after approval, timelines for postmarket commitments remain central to safety transparency, payer confidence, and long-term label management.