FDA leaders Califf and Pazdur dish on accelerated approval reforms, single-country trials and an empty White Oak
FDA Commissioner Rob Califf sat down for a conversation on Thursday morning with Rick Pazdur, head of the FDA’s Oncology Center of Excellence, with the two agreeing that accelerated approval reforms need to happen, that multi-regional clinical trials are always better than single-country trials, and that returning every last FDAer to the White Oak campus doesn’t make sense.
The conversation, conducted as part of the Friends of Cancer Research’s annual meeting, began with Califf’s questions on the empty space around White Oak as routine staff have mostly moved their operations to the more versatile virtual setting, and as advisory committee and all industry meetings remain virtual.
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