RE: FDA's Emergency Use Authorization Timeline

[Zara Schaffer]

I have a question re FDA’s approval process for Investigational Device Exemption (IDE).  On the FDA website, it says it’ll take 30 days or less to approve an IDE application:

 

“An IDE application is considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved.”

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process

However, with some companies, I noticed it takes far longer than 30 days.  For example, Check-Cap submitted an IDE application on Oct 9, 2018, but it didn’t receive approval until Dec 13, 2018, which is far longer than 30 day

https://www.prnewswire.com/news-releases/check-cap-announces-ide-submission-to-fda-for-its-c-scan-system-300727577.html

https://www.prnewswire.com/news-releases/check-cap-announces-fda-conditional-approval-of-ide-to-initiate-us-pilot-study-of-c-scan-300764947.html

 

Why is this?  Is this considered normal?  Wouldn’t FDA be in violation of its own timeline rules?  Please help.  I’m trying to figure this out.

Edited September 12, 2022 by Zara Schaffer
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[Zara Schaffer]

Hi, I’m trying to find a reliable timeline for FDA’s Emergency Use Authorizations (EUA’s).  With FDA’s BLA and NDA applications, it’s 10 months or 6 months with Priority Review.  But I can’t find anything on EUA’s except for a very general “it can be fast” timeline found on the FDA website (and I know some EUA’s that have taken months, though only like around 3, which is even shorter than Priority Reviews):

 

“FDA is prepared to issue EUAs expeditiously (e.g., within hours or days) when circumstances warrant and adequate information has been made available for prior review through pre-EUA interactions.”

 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities

 

So does anyone know timeline/deadline for FDA’s EUA’s—or at least within what period most EUA’s fall into (before 3 months, before 2 months, etc.)?

[CharonY]

RE: IDE, what often happens is that reviewers request additional info which will extend the timeline, especially if there is any potential risk to the participants.

Likewise the timeline for EUAs cannot be easily generalized, as it depends on too many factors. If the application is straightforward, documentation is great and the need is high, it will be on the lower end of the spectrum. Conversely, if the application is risky/novel and/or poorly documented then emergency use might be delayed significantly.

Generally panels have to decide based on available data and past experiences (if applicable) and each case can be very different and has to be treated differently. It is not like a simple checklist.

[Arete]

Having submitted a few EUAs for phage therapy applications - CharonY is on the money. The FDA will REVIEW your EUA within 30 days (significantly faster if time is of the essence, I've experienced a 48 hour turnaround for a critical sepsis patient) but there's no guarantee that the review will result in a final decision. If the review results in a request for additional data, then it's on the applicant to get the data and resubmit, which can take a long time dependent on the type of data requested. Then your 30 days potentially resets. 

I would say in my experience that the likely impact, number of patients, etc plays heavily into the review process e.g. if it's one patient who will definitely die without experimental therapy vs a vaccine for millions of otherwise healthy children, vastly different levels of scrutiny and expected justifying data will be applied.