ABSTRACT
THE DRUG DEVELOPMENT PLAN Industry sponsors develop an overall plan for how the proposed investigational agent should be studied to provide evidence to the Food and Drug Administration (FDA), in the form of a New Drug Application (NDA), of the safety and effectiveness of the investigational agent. These plans are referred to by a variety of names: Drug Development Plan, Clinical Development Plan, Project Management Plan. The purpose of an overall drug development plan is to anticipate questions raised by the FDA about the investigational agent and to design studies to answer these questions. Generally, they evaluate each trial from the Phase I studies (to establish dosing, pharmacokinetics, etc.) to the proposed Phase I1 and I11 studies (for safety and efficacy trials in patients). All of this information is pooled together to create the NDA document for submission to the FDA. Each individual study protocol fits into this overall plan.
