News Focus
News Focus
icon url

kund

12/11/24 12:10 AM

#476507 RE: Steady_T #476506

With the FDA, there is a guarantee that you will receive a decision by the specified time. However, with the EMA, there is no such guarantee—they can continue reviewing and asking questions indefinitely. The 210 days are active days, meaning if the file is not touched on a given day, that day is not counted.

With Misleading's execution style, the clock stop could extend the process for years....