Office Of New Drugs Reorg Is Bigger Than Expected: US FDA Adds 11 Review Divisions
Long-planned OND 'modernization' to better match workflow, allow more time with stakeholders includes proposed restructuring that would boost number of offices overseeing review operations (adding four for a total of nine) and drug review divisions (adding 11 for a total of 30).
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FDA’s interactions with sponsors to support drug development activities are generally timely and effective – but industry still sees room for improvement in assuring ‘best practices’ are followed across all divisions.
OND will grow to eight offices and 27 clinical divisions, which is slightly different than an early proposal.
The FDA did not expect to meet many FY 2018 goals for on-time scheduling of formal PDUFA meetings or issuing written responses in lieu of meetings.