US FDA’s Regulatory Affairs Office Building Case For More User Fee Funding
ORA represented only a small fraction of the user fee programs’ costs in recent years, but wants to show its importance to the review process.
You may also be interested in...
Industry feels that sufficient program management tools are in place, but a PDUFA VII negotiator says they need more time to mature.
The House Appropriations Committee also does not want the agency to become too dependent on alternative inspection tools.
Foreign facility visits may take longer to reach usual levels because of the ongoing coronavirus outbreaks in other countries.