Published in Medical Letter on the CDC and FDA, April 17th, 2005
The clinical plan to support a new drug application (NDA) approval for KRX-101 under Subpart H (accelerated approval), as agreed upon with the FDA under an SPA, consists of (i) a single phase 3 trial in patients with microalbuminuria based on the surrogate marker of regression of microalbuminuria as the primary endpoint; (ii) supportive data from previously conducted...
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