1Feasibility: During this phase, discussions are in progress to determine if the drug development tool has sufficient priority based on its potential impact on public health and value to both the industry and regulatory agencies to justify launching a project to proceed toward a regulatory qualification submission.
2Scoping: During this phase, the project’s goals, objectives, deliverables, timeline, and budget are being developed.
3Research: During this execution phase the project team is actively engaged in carrying out the research plan.
4Submission: During this phase, a qualification dossier that reports the results of the research project and supports the context of use of the novel drug development tool is being prepared and will be submitted to the agency as indicated by the color code.
5Qualification: During this phase, the regulatory agency is reviewing the submission and will issue an opinion regarding the proposed utility of the novel drug development tool. When qualification decisions are made, links to the regulatory decisions will be provided at this site.