Healio (9/28, Miller) cites researchers in reporting that “the FDA has often approved new drug applications for opioids based on trials of inadequate length that included only patients who could tolerate the drugs.” The researchers “examined 48 new drug applications (NDAs) that were approved by the FDA between 1997 and 2018.” The trials that supported the applications “lasted a median of 84 days” though according to one researcher, many patients would take these medications for longer than that. The findings were published in Annals of Internal Medicine.
Related Links:
— “FDA approved opioids based on limited data, sometimes ‘flawed’ trial designs “Janel Miller, Healio, September 28, 2020