It does create moats where non existed before. I do think the government over-estimates how well and up to date it keeps its standards. I don't know if it's s

It does create moats where non existed before. I do think the government over-estimates how well and up to date it keeps its standards. I don't know if it's still true, but 8 years ago (2015), you had to submit documentation to the FDA on CDROM. No. You couldn't just upload it.