Coverage dated September 18, 2026 to September 22, 2026
The drugs and devices have been on the market for years, but FDA-ordered studies still aren't done
Headline from MedicalXpress
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.
MedicalXpress's own description from its feed. We collect headlines and these descriptions, not full articles; read the original reporting below.
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.
An analysis of FDA data found hundreds of postmarket studies running behind schedule, raising questions about the agency’s ability to ensure manufacturers follow through.
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.
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.
