CDER Director Woodcock Plans Changes To Drug Reviews During OND Transition
In podcast interview, US FDA’s Center for Drug Evaluation & Research Director Janet Woodcock discusses her plans the Office of New Drugs, including changes to the structure of the office to make reviews better managed and more uniform across divisions. Woodcock says she expects to stay in the interim OND role for most of 2017.
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OND will grow to eight offices and 27 clinical divisions, which is slightly different than an early proposal.
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).