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eagle-eye

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eagle-eye

Re: rkcrules2001 post# 3101

Thursday, 04/26/2007 3:48:25 PM

Thursday, April 26, 2007 3:48:25 PM

Post# of 12660
DNDN has been dealing with CBER since (I think) about 1993. It is a cancer drug now and was a cancer drug then. Why would they switch approval authority to CDER when the BLA was filed.

CBER was in control of this drug for over 10 years, they have all the expertise and knowledge to review the application.

It is a biologic drug and it is in the correct division. Just because the indication is cancer does not mean CDER is the proper authority to make the approval decision.

IMO, CDER is PO that the future of cancer treatments will gradually shift away from them. Rightly so and to the benefit of all cancer patients!
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