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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User fee reauthorization negotiators from US FDA and industry divide into subgroups to tackle specific issues before moving to the broader agreement.
US FDA says sponsors generally won’t need to publicly disclose company or product if selected for pilot, but rather elements about design of their complex trial.
FDA wants to publicize some aspects of designs accepted into pilot, which might discourage industry participation.