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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From pre-med to pharma lab rat to deputy director of operations at the FDA, Khushboo Sharma, a 2021 In Vivo Rising Leader and current VP of science and regulatory affairs at BIO, has spent her career pursuing a goal she says the FDA and biopharma industry have in common: ensuring that innovative drugs get to patients.