Zortress Approval Delay Caused By Novartis Attempts To Avoid Controlled Trial Of Dosing Regimen
This article was originally published in Pharmaceutical Approvals Monthly
Executive SummarySponsors cannot cut corners in developing clinical data to support a revised dosing scheme, even when a drug’s efficacy has already been shown, Novartis learned while shepherding its kidney transplant agent Zortress (everolimus) through the FDA approval process.
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