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CDER Vs. CBER: Consulting As Usual, Or Hints Of Inter-Center Power Struggle?

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

In the Provenge review documents FDA has released so far, there is little indication of overt struggle between the drugs and biologics camps - but many signs that the overheated public and media atmosphere was making the agency especially careful in its dealings with the sponsor.

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FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011





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