Therapeutic Solutions International Inc (TSOI)

[deut8-18]

EAU timeline info if not previously posted, on my phone hope the link works
https://camargopharma.com/resources/blog/emergency-use-authorizations-what-is-an-eua-and-does-your-product-qualify/

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.

Camargo is actively supporting clients as they navigate the EUA process with the FDA. Sponsors who are developing MCMs for the diagnosis, prevention, or treatment of COVID-19 can reach out to Camargo’s team for support with their EUA request?here.