Drug development process
.................................................................................

Pharmaceutical and biotechnology companies that develop human therapeutic products undertake a sequence of major phases comprising research, pre-clinical studies and clinical studies. The major milestones on the pathway to gaining approval to market a drug in the US are the filing of an Investigational New Drug (IND) application allowing commencement of clinical trials and subsequent receipt of a New Drug Application (NDA) approval.

The process of completing clinical testing and obtaining regulatory approval for a new drug product can take many years and require substantial capital and other resources. Research and development activities are subject to significant regulation by various governmental authorities in the US and other countries. In the US, pharmaceutical products intended for therapeutic use in humans are governed by the Food and Drug Administration (FDA) regulations. There are comparable regulations in other countries.

Major drug development phases and milestones
            (point and click below to see more)