Forty-Eight US FDA Drug Application Decisions Delayed By Pandemic's Deferred Inspections
Executive Summary
US FDA 'resilience' report charts how inspection backlog grew and impacted approvals and compliance follow-up.
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As Congress beats the drums for surprise inspections abroad, the agency plans a statistically rigorous comparison of announced versus unannounced inspections. Meanwhile, as authorities shed COVID-19 precautions, FDA investigators flood back into the field domestically, with surge of foreign inspections to follow soon.
House Appropriators Continue Pressing US FDA To Conduct Surprise In-Person Inspections
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