Richard Pazdur, one of the most powerful regulators at the Food and Drug Administration, flung open the door to Chinese cancer drugs a few years back. But now, Pazdur is closing that door — a reversal that has implications for Chinese drugmakers and their U.S. partners.
Writing in Lancet Oncology late last week, Pazdur described imported cancer drug data from China as a “bridge over troubled waters” before raising a host of concerns about the prospect of using them as the basis for regulatory approval. The views he expressed were a marked contrast to earlier remarks in which he seemed to embrace the idea of the FDA giving the green light to cancer drugs developed in China.
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