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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Omnibus package also gives FDA expanded authority over nicotine products and creates President Biden’s Advanced Research Projects Agency for Health.
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.
The bill also would give the FDA expanded authority over nicotine products and create President Biden’s Advanced Research Projects Agency for Health.