I typically link to the Federal Register when referring to documents like this. The Federal Register notice and the associated Regulations.gov docket frequently constitute most of the the statutorily-required public notice and comment procedure. For example:
Docket No. FDA-2020-N-2358
To put it generally, I have some experience with the FDA application and approval process. People often misunderstand the risk-benefit calculus (I loathe this phrase) FDA uses when approving a new drug product. When dealing with conventional approvals on an accelerated pathway, there is reduced clinical, stability, and other data. FDA is willing to forgo this for either something that is already well-understood (there are special types of applications for this), or for something with an immediate medical need. Emergency Use takes this even further and side-steps much of the typical review process altogether, because the need is determined to be that dire. This doesn't necessarily mean something is or isn't safe, just that there is much less data and scrutiny than something that's actually approved.
I can say from experience that you should not trust FDA to have your personal interests in mind here. Equivalent products are treated differently even when dealing with conventional applications, because there is a significant amount of politics behind all FDA decisions. The legal terminology here would be "arbitrary and capricious". However, the judicial branch generally grants FDA extreme deference on all scientific matters, so they're frequently not held accountable for wrong decisions. It's all part of the game pharma companies play.
I generally link to the Federal Register when referring to documents like this. The Federal Register notice and the associated Regulations.gov docket generally constitute most of the the statutorily-required public notice and comment procedure. For example:
Docket No. FDA-2020-N-2358
To put it generally, I have some experience with the FDA application and approval process. People often misunderstand the risk-benefit calculus (I loathe this phrase) FDA uses when approving a new drug product. When dealing with conventional approvals on an accelerated pathway, there is reduced clinical, stability, and other data. FDA is willing to forgo this for either something that is already well-understood (there are special types of applications for this), or for something with an immediate medical need. Emergency Use takes this even further and side-steps much of the typical review process altogether, because the need is determined to be that dire. This doesn't necessarily mean something is or isn't safe, just that there is much less data and scrutiny than something that's actually approved.
I can say from experience that you should not trust FDA to have your personal interests in mind here. Equivalent products are treated differently even when dealing with conventional applications, because there is a significant amount of politics behind all FDA decisions. The legal terminology here would be "arbitrary and capricious". However, the judicial branch generally grants FDA extreme deference on all scientific matters, so they're frequently not held accountable for wrong decisions. It's all part of the game pharma companies play.