The FDA says the drug Tavneos was approved on the basis of manipulated study data, but pulling an approval already granted is proving difficult. Ars Technica
Ars TechnicaThe FDA wants to pull its approval of a drug. It’s not so easy.The regulator says Tavneos was approved on the basis of manipulated study data. Should patients still have access to it?
If an approval rested on bad data, should patients already benefiting keep access while the question is settled?