It's not like you can pop down to the 7-11 and pick up an NDA.
There is a process that has to be gone through. It's a long and carefully structured process designed to protect the public from drugs that don't work or have a bad side effect to benefit ratio.
All the things you list are part of the process.
Yeah I get that it takes a long time. I, like most others, would like the process to go faster.