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Ned Sharpless

Norman "Ned" Sharpless, MD — former Director of the National Cancer Institute and former Acting FDA Commissioner, now advisor and commentator on cancer research and FDA policy.

Jul 31, 2025

31:41
sort
31:41
of agree.
31:42
I mean, I think, you know, accelerated approval is sort of where the rubber meets the road, particularly in oncology.
31:49
You know, 80 percent of accelerated approvals are cancer products.
31:52
And if that's available as a pathway to get your product on the market, it's very attractive.
31:58
It means that you can work on certain kinds of programs that you would not be able to work on if they required a large randomized phase three trial for approval.
32:05
So I think that the posture of the agency on accelerated approval has been a real driver of, you know, rare disease research and, you know, oncologic, you know, unmet medical need research, I guess is the best way to describe it.

6 MINS LATER

38:35
I just want to get maybe your reaction to that and also just your thoughts on what the FDA can do to sort of better detect side effects, fatalities, things like that in the kind of a post-marketing setting.

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