New study of FDA cites the flaws behind rapid-fire cancer drug OKs
Over the past few years the FDA’s oncology group under Richard Pazdur has truly revolutionized the way cancer drugs are developed and reviewed for marketing approval. In order to ramp up the arrival of new drugs, regulators waived old rules on overall survival, flagging their willingness to carve years out of the R&D process in order to field new therapies.
It was a straight up trade off. The FDA was willing to accept preliminary evidence of efficacy and safety and delay confirmatory studies until after a drug was on the market. And patient groups have cheered the FDA on at every turn.
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