Want A Predicable Review For Your NDA? Use eCTD And Don't Amend It
This article was originally published in Pharmaceutical Approvals Monthly
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Strategic plan says CDER will streamline its processes and may find activities that could be “cut altogether.”
Technical deficiencies foil the resubmission of Chelsea Therapeutics’ Northera. The company thinks it can resolve the problems quickly and some analysts expect a relatively short delay of one or two months to the user fee date.
Members will enter data into secure database, allowing trade groups to gauge trends and problems with the PDUFA V application review program – and giving industry a stronger negotiating position for the next user fee round.