Sponsor/FDA Meetings (End of Phase 2)

The primary focus of "end of Phase 2" meetings is to determine whether it is safe to begin Phase 3 testing. This is also the time to plan protocols for Phase 3 human studies and to discuss and identify any additional information that may be required to support the submission of a new drug application. It is also intended to establish an agreement between the Agency and the sponsor of the overall plan for Phase 3 and the objectives and design of particular studies. These meetings avoid unnecessary expenditures of time and money because data requirements have been clarified.

One month prior to the "end of the Phase 2" meeting, the sponsor should submit the background information and protocols for Phase 3 studies. This information should include data supporting the claim of the new drug product, chemistry data, animal data and proposed additional animal data, results of Phase 1 and 2 studies, statistical methods being used, specific protocols for Phase 3 studies, as well as a copy of the proposed labeling for a drug, if available. This summary provides the review team with information needed to prepare for a productive meeting.

Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.