Trial Simulation, Drug Selection To Be Focus Of US FDA's Drug Development Modeling Pilot

Meeting requests from sponsors that focus on safety prediction will also be prioritized.

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The US FDA is set to begin accepting requests to participate in its model-informed drug development (MIDD) pilot program, but the agency will "initially prioritize" meeting requests from sponsors that focus on dose selection, clinical trial simulation and predictive or mechanistic safety evaluation.

In an April 16 unpublished Federal Registernotice, the agency announced it would begin accepting requests to participate in the...

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