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

24 Jun 2020

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.

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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...