Submitted Data Confirm Doxil's Clinical Benefit, J&J Maintains
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's Oncologic Drugs Advisory Committee will review on Nov. 8 unfulfilled accelerated approval trial commitments for products approved before 2002.
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FDA Advocates Single Phase III/IV Trial For Accelerated Approval Oncologics
Interim analysis of accelerated confirmatory trials could improve Phase IV completion rates, Office of New Drugs Medical Officer Vicki Goodman says at DIA annual meeting.
FDA Advocates Single Phase III/IV Trial For Accelerated Approval Oncologics
Interim analysis of accelerated confirmatory trials could improve Phase IV completion rates, Office of New Drugs Medical Officer Vicki Goodman says at DIA annual meeting.
Post-Marketing Commitments To Be Studied Under FDA Contract
Study will examine consistency of processes for designing and implementing Phase IV trials within and between FDA divisions, Deputy Commissioner Gottlieb says.