Pharmaceutical Approval Process During Pandemic

A pharmaceutical company would have to prove that a product was safe before it

accessed the market. So you prove safety, and you do that through

rigorous testing. The testing would include clinical

examinations.

It would include, you know, lab work. You'd look for biomarkers.

You'd do extensive testing. It would take years to complete

that trial, and then at

the end of the trial, you would look at the results,

and you would be able to say,

"Is it safe or is it not, and does it meet the standards for, um,

regulatory approval?" However, during the pandemic, because this was

a public health crisis, a new emergency framework was

put in place, and they were able to conduct approvals based on

what they call

rolling reviews. And a rolling review basically means

that you get to take

sneak peeks at the trial, and if there's an early sign of benefit,

then you

actually get to approve the product based on that early data.

So these products were approved based on two months of data