New Drug Application (NDA)

Following the completion of all three phases of clinical trials, a company analyzes all of the data and files an NDA with FDA if the data successfully demonstrate both safety and effectiveness. The NDA contains all of the scientific information that the company has gathered. NDAs typically run 100,000 pages or more. By law, FDA is allowed six months to review an NDA. The average NDA review time for new molecular entities approved in 1997 was 16.2 months.

Click here for NDA Chart

Click here for Application Process