What signifies that a development program for an investigational product is considered "discontinued"?

A development program for an investigational product is considered "discontinued" when the company does not expect to resume development. This characterization is crucial in clinical research and regulatory contexts because it signifies a definitive decision that further development is not deemed viable, whether due to safety concerns, lack of efficacy, market considerations, or strategic shifts within the organization.

This differentiation clarifies that, while the company may have halted certain activities (such as trials or research initiatives), it is the lack of an expectation to resume development that solidifies the status of a program as "discontinued." In practice, this may inform regulatory bodies, stakeholders, and sites involved that the investigational product will not be moving forward in the pipeline, which can have implications for resource allocation and potential financial reassessment.

In contrast, simply stopping research activities or uncertainty about future development do not necessarily indicate a formal discontinuation. The term does not imply that all trials must be canceled immediately, as there can be scenarios where trials are paused but not officially discontinued. Thus, the clear delineation that there is no expectation for development to resume is what solidifies the understanding of the program's status as discontinued.