What timelines should you expect for the review process?
In a critical ongoing or imminent situation, the FDA aims to review EUAs within hours or days. For instance, the FDA issued EUAs for COVID-19 diagnostic tests to Roche, Thermo Fisher Scientific, and Abbott Laboratories within 24 hours of their request submissions.
However, the timeline for FDA action on an EUA request depends on several considerations, such as the regulatory history and profile of the product, the level of pre-EUA communication with the FDA, and the seriousness of the emergency.
The FDA has also established priorities for its review of EUA requests:
- The circumstances of the emergency
- The public health need and urgency of treatment
- The amount of safety and efficacy evidence
- The risks and benefits of the product
- The availability of the product (manufacturing capabilities and stockpiles)
- The availability of alternative MCMs
It is important to realize that an EUA does not signify FDA approval, licensure, or clearance and is not an accepted endpoint for product development. In general, an EUA will remain in effect only for the duration of the EUA declaration under which it was issued. Sponsors should continue to develop their product, working towards FDA approval after the termination of the emergency. In fact, the FDA encourages Sponsors to design and conduct appropriately controlled clinical trials during the emergency response.
So, it should only take a week or two from submission, I don’t think they have submitted yet. Given the emergency will probably be around for at least another 2 years, NanoDX will have plenty of time to complete the normal regulatory process before the EUA is rescinded.
