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.
In an interview with STAT, Pazdur, director of the FDA’s Oncology Center of Excellence, acknowledged his view had changed.
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