The Drugs and Devices Have Been on the Market for Years. But FDA-Ordered Studies Still Aren’t Done.

To get drugs and devices out faster, the FDA lets companies conduct studies of safety or efficacy after the products are approved. In many cases, such “postmarket” studies are behind schedule or overdue, records show.

By: David Hilzenrath

Outlets: KFF Health News

Published: September 18, 2026

Words: 2,495

Last Updated: 7 hours, 48 minutes ago

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When the FDA was deciding whether to approve the drug Tavneos several years ago to treat a set of rare autoimmune diseases, agency experts argued that would be a mistake, according to FDA records.

One problem cited: The manufacturer had provided only “limited safety data.”

As it often does, the FDA in 2021 approved the drug with a proviso: It required the manufacturer to conduct an additional years-long safety study once the …

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