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.
You may also be interested in...
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).
US FDA pilot program linking drug approval documents to sponsors' clinical study reports will improve review efficiency and access to information by medical researchers and drug developers, commissioner says; move also could aid sponsors when it comes to reimbursement decision-making, Foley and Lardner's Rosen predicts.