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Hahn Praises FDA Staff For Meeting User-Fee Goals While Adjusting To COVID-19

In a 23 June blog post, FDA head Stephen Hahn issued a statement praising agency staff for continuing to meet their statutory obligations under MDUFA V considering the added difficulties of working through the coronavirus pandemic. While noting the agency is being creative in how it works in its new COVID-19 reality, he cautioned the FDA may not be able to meet those deadlines in the future if things continue as they are. Hahn also in his blog post addressed in-person inspections of manufacturing facilities.

Stephen Hahn of MD Anderson Cancer Center is expected to be nominated for FDA commissioner
Stephen Hahn

Stephen Hahn, commissioner of the US Food and Drug Administration, said he’s proud that agency reviewers have been able to maintain their user-fee obligations despite the FDA seeing an increased workload related to the COVID-19 pandemic and drastically changing the way it operates to accommodate best public-health practices.

The statement comes a day after the agency issued a guidance document stating the pandemic could lead to missed user-fee deadlines. (Also see "Pandemic Could Cause FDA To Miss...

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