Forty-Eight US FDA Drug Application Decisions Delayed By Pandemic's Deferred Inspections
US FDA 'resilience' report charts how inspection backlog grew and impacted approvals and compliance follow-up.
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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.
ORA continued to spend user fee dollars despite its inability to travel for facility inspections, while CBER found little generic and biosimilar work during FY 2020.