Chapter 6

The New Drug Application, which is submitted to the FDA. It is the application submitted for marketing approval.

Phase 1 consist of a small group of healthy volunteers where they are tested for the maximum tolerance of the drug.

Phase II involves the diseased large group of people to test the effectiveness of the drug.

Phase III is the final test before the application is submitted to the FDA. It consist of many trials in several facilities and often test the drug against other drugs for relative effectiveness.

It is the Phase after the drug has been approved by the FDA. At this time, the drug is examined for any possible side affects.

Between 12-16 years

The Investigational New Drug Review is a process of application to be able to ship unapproved drugs across state lines.