Health
The drugs and devices have been on the market for years, but FDA-ordered studies still aren't done
When the U.S. Food and Drug Administration (FDA) was deciding whether to approve the drug Tavneos several years ago to treat a set of rare autoimmune diseases, but agency experts argued that would be a mistake, according to FDA records .
AI Summary
The FDA approved the drug Tavneos in 2021 to treat a group of rare autoimmune diseases. During the approval process, FDA experts warned that approving the drug could be a mistake. The approval included a condition that the manufacturer must conduct a one‑year safety study after the drug entered the market. The study is intended to monitor long‑term safety and effectiveness of Tavneos. The FDA has not yet completed the required post‑market study.
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