But instead of doing that you’ve decided to just write this comment instead and post something that looks quite silly for those that have taken the first approach.
[1]https://www.fda.gov/science-research/science-and-research-sp...
The numerous “not approved” decisions makes that plainly obvious. Not to mention all the times FDA has said “you have to do X to get approved” and the company happily complies despite it delaying sales by several quarters.
To the question at hand “why do publications come after FDA approval”, the FDA has access to all the data (actually more) before publication, so the publication is irrelevant to approval.
The company happily complies?
Or just does it begrudgingly because not doing it delays sales a few more quarters if not indefinitely?
I'm not sure where you're getting the idea from that a company would happily do anything additional. It's a cost of doing business. Let's not pretend they're angels, they're in it for the money not the greater good.
And if that last statement needs a rationale, tell me who is doing the work to find the next antibiotic or any other non chronic disease medication
Even if the cost of the change are very high, getting it approved is probably worthwhile. To say that they would do so happily implies that there's a motive beyond getting approval.
Based on these comments, maybe my interpretation was just off