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.
You may also be interested in...
Some US FDA Decisions May Have Been Different If Technology Had Been Upgraded, Woodcock Says
Principal Deputy Commissioner Woodcock is overseeing an enterprise-wide technology campaign intended to improve access to agency information and data.
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.