With the influx of “new drug applications” taking up a larger percentage of labor hours, the FDA had to turn to some other alternatives for help. The agency already has a program in place from the 1990s, called the Prescription Drug User Fee Act (PDUFA), which outlines the guidelines and metrics for the FDA to review a drug. Drug companies pay significant fees to the agency when submitting their applications, which now totals more than $2.8 trillion for trials involving clinical data.
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