RE:RE:FDA priorityKingpin68 wrote: The remainder of Richard Pazdur's quote: ..Our staff is continuing to meet virtually with drug developers, academic investigators and patient advocates to push forward the coordinated review of drugs, biologics and devices for cancer. Would there be a lot of other 'devices' for cancer being looked at by the FDA besides TLT's. I'm really looking forward to what's coming.
Let's hope we are part of that 9/10 who gets the FDA nod. I'm assuming TLT consulted/hired the right experts to adequately answer all deficiencies. I can't imagine this trial not getting the nod considering we had already been greenlighted in Canada....Canada being USA's little brother in the context of clinical trial regulations/requirements.
As for Dr. Pazdur's statement re: pushing forward the review of "devices" for cancer, I wouldn't read too much into that statement. There are currently thousands of trials using some form of device for either diagnostics, monitoring, control of side effects, or as an adaptation for treatment. Nonetheless, this pandemic has changed many scientific & influential mindsets/thresholds. IMO, the bar has been lowered, especially for oncology trials....there will be increased pressure towards improving regulatory efficiency (cutting out a little more red tape) & getting promising cancer therapies to market sooner.