Making drugs is a ridiculous process. I had the pleasure of listening to a physical chemist describe every single step it took for his team at Abbott labs to take Lopinavir/ritonavir to market. It is incredible how difficult it is to go from novel molecule to phase IV. Every single thing he did he had to, by FDA guidelines, be written and documented appropriately. Everything is highly scrutinized. With medicine we need to be right and we need strong scrutiny, because when there isn't oversight shortcuts are made. That's just the federal guidelines, the chemistry behind drug production, and this is something I find interesting but strongly dislike the amount of math behind physical chemistry, is intimidating. Some of the questions that need to be answered are: Does this molecule affect any enzyme? Is this enzyme hypothesized to be in a disease process? What is the structure of this molecule? How is it made? How can we make more? How can we make more more efficiently? Does this drug work in people? What's the dose that needs to be given to have an effect? What is the dosing ranges for a given drug? What are the serious side effects? What are the moderate/mild side effect? How is this drug cleared/excreted? Are there certain populations which this is contraindicated in?
These are some of the main questions that are answered when taking a drug to market, which is why it usually takes 10 years and billions to go from novel molecule to FDA approved drug.