Gottlieb Promotes 'Team' Work For Product Reviews
US FDA Commissioner intends to change agency's siloed structure and move reviewers into teams that will follow products pre- and post-market.
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All NMEs and original BLAs are expected to adhere to the team-based review approach by the end of the year, with expansion to other application types later.
Like ANDA evaluations, US FDA plans to use the word assessment to describe them for NDAs and BLAs.
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).