"everything that is illegal for normal pharmaceuticals is now legal as long as Prep Act window remains open for them."

Listen to what @sasha_latypova former Pharmaceutical R&D Executive has to say about these EUA products. Hint, it's not good.

"Everybody assumed that these vaccines were going through this pathway, turns out they were not. They are a complete different category of product that… pic.twitter.com/H3ugr6DP84

— HealthRightsMA (@HealthRightsMA) February 13, 2024

Completely different category of product which the federal government created called EUA, Emergency Use Authorization, and this category only exists under Public Health Emergency or Prep Act declaration by Health and Human Services Secretary.  So under this particular category they are regulated by a completely separate section of Food, Drugs, & Cosmetics Act, FDA, which says that "everything that is illegal for normal pharmaceuticals is now legal as long as Prep Act window remains open for them."  And as we know for COVID, the PREP Act window is open until December of 2024.  And now we also have a window open for Ebola, Marburg, and other things until the end of 2028.  And I assure you the federal government fully intends to keep these Prep Act declarations going in perpetuity because there is no way on this planet these products can comply with normal regulatory requirements.  They tried for 20 years and they failed every time.  So they decided to go on the market anyway by creating this new regulatory status for themselves.  

So under this regulatory status, there is no IRB (Institutional Review Boards) requirement. 

There is no informed consent requirement.

There is no requirement for any compliance with good manufacturing practices; rather, it says you can do it as a manufacturer voluntarily but there is no enforcement and clinical trial data is completely irrelevant.  

Also, these things can coexist with what's fully approved versions except, of course, these products have never been approved normally under investigational status and, therefore, there is no fully approved version.  There is only an EUA.  And only EUAs have always been shipped in the US with drug inserts arriving blank.  And they never complied with any rules or requirements.