CBER Review “Paradigm Shift” Credited With Improved Cycle/Review Stats
This article was originally published in The Gray Sheet
Executive Summary
The Center for Biologics Evaluation & Research is working to identify problems with premarket applications earlier so they can be resolved in the first cycle of review, according to Robert Yetter, CBER associate director for review management
You may also be interested in...
Device Review Templates Are Milestones On Road To “Critical Path” – CBER
The Center for Biologics Evaluation & Research is flagging areas of the device review process that can be clarified through "templates" to guide staff and sponsors
Device Review Templates Are Milestones On Road To “Critical Path” – CBER
The Center for Biologics Evaluation & Research is flagging areas of the device review process that can be clarified through "templates" to guide staff and sponsors
CBER Should Retain Jurisdiction of Assigned Device Reviews – HHS Report
Improved device review times, including speedy handling of West Nile Virus diagnostics, convinced HHS that the Center for Biologics Evaluation & Research should retain jurisdiction over blood and tissue-related devices already assigned to the center