Hacker Newsnew | past | comments | ask | show | jobs | submitlogin

No, because the FDA doesn’t have the resources to actually redo a trial.

What they do is ask the manufacturer to lay out how they run the trial before they start.

If you bring data back to the FDA that doesn’t match up (fewer patients, different measurements) you can expect a rejection.



Guidelines | FAQ | Lists | API | Security | Legal | Apply to YC | Contact

Search: