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Pandemic Could Cause FDA To Miss User-Fee Deadlines

Executive Summary

In a new temporary guidance document from the US FDA, the agency says while it’s still meeting its deadline obligations for premarket applications under its user-fee agreement with industry, it may end up missing future deadlines due to strains on the agency from COVID-19. In such cases, the FDA says it will get back to the sponsor about setting a new estimated deadline.

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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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