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.
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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.
The largest medical device lobby group will host its annual conference online instead of in person. The meeting that had been set to occur over three days in Toronto will now take place in September and end in October.
The COVID-19 crisis had already forced the US FDA to postpone its first public meeting on the medical device user-fee negotiations to early next May, which was to be webcast. Now the agency has postponed the meeting indefinitely.