ANDAs Showing Steady Improvement In First-Cycle Approval Times
First-cycle approvals took longer than multi-cycle approvals in the generic drug user fee program's first year, but decreased dramatically in year two.
You may also be interested in...
Beginning confirmatory trials before the accelerated approval is granted shortens the time between clearance and the confirmation of benefit, when patients are at risk, said Oncology Center of Excellence Director Richard Pazdur.
CBER Director Peter Marks said more sophisticated manufacturing expected in the next decade could lead to questions about whether gene therapies should be regulated by his center or CDRH.
Agency employees will have on-site, telework and remote possibilities, but options will depend on the center, office and job duties.