Phase IV Commitments Proceed According To Schedule, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA releases tally of postmarketing commitments for FY 2005 in annual report.
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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.
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.