The first action for a manufacturer desiring FDA approval for a new drug is to
perform laboratory and animal tests
First step involves using animals subjects to test the drug efficacy and the n secondly developing a prototype of the drug
There are steps taken before the drug is approved all of which aim to ensure that the drug is fit for human use and provides the benefit of dealing with the condition better than the existing drugs or in a safer manner. Firstly, basic scientists work in the laboratory and with animals; secondly, a drug or biotechnology company develops a prototype drug though the company must seek and receive FDA approval, by way of an investigational new drug and then what follows is an application (IND), to test the product with human subjects.