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Pandemic Could Cause FDA To Miss User-Fee Deadlines

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.

Deadline concept illustration in comic book style. Vector alarm clock and Deadline word on pop art background.

The US Food and Drug Administration may miss future user-fee deadlines as it grapples with the ongoing COVID-19 pandemic, according to a 22 June emergency guidance document from the agency. In such situations, it will issue a letter to the product sponsor explaining the delay and a new estimated date for the decision.

Since the coronavirus crisis hit, the FDA has been busier than ever not only trying to do its part to...

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