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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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Appropriators Continue Pressing US FDA To Conduct Surprise In-Person Inspections

Omnibus package also gives FDA expanded authority over nicotine products and creates President Biden’s Advanced Research Projects Agency for Health.

US FDA Takes A Scientific Look At Hot-Button Issue Of Unannounced Foreign Inspections

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

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

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