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.
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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.
Agency is considering posting its observations from remote assessments of facilities, assistant commissioner Miller tells annual FDLI meeting; new FDA Inspectional Activities Council will develop an action plan for the agency’s inspections program.