You can spend hundreds of millions of dollars before you even get to the point where you can ask the FDA if you can start human trials. Even having spent all that time and money, you still won't have any guarantee that your drug will prove to be safe, effective, or better than any existing drugs.

There's a metric ton of other regulations, at least in the US, mandating how any human level research is done. Depending on what one is doing, it's not necessarily less annoying

Or just create your own country. Failing that, there's always international waters. Bonus points if the lab is underwater.

Edit: Hah! http://www.dailymail.co.uk/sciencetech/article-2568744/Float...

ANVISA (Brazilian equivalent of the FDA) has more regulations than FDA for most subjects.