Earlier quoted context omitted.
There’s a specific regulatory pathway for this process, section 505(b)(2). It allows you to use the safety data for the approved treatments which can save you a lot of time and money (I have used this route for a drug myself T one of my companies). You still have to prove that your formulation is safe,of course, and prove efficacy for the situation you intend to market it for.
Gotcha, and that makes sense. Seems like a big time saver regardless. Are we talking months or years, that are shaved off?
I think the current stats are that the average drug time to approval is 14 years.