Trial Simulation, Drug Selection To Be Focus Of US FDA's Drug Development Modeling Pilot
Executive Summary
Meeting requests from sponsors that focus on safety prediction will also be prioritized.
You may also be interested in...
PDUFA VII: Human Factors Review, Finance Flexibility, REMS, And Manufacturing Get Attention
User fee reauthorization negotiators from US FDA and industry divide into subgroups to tackle specific issues before moving to the broader agreement.
Complex Innovative Designs Pilot Likely Satisfies Industry's Disclosure Worries
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.
US FDA's Complex Trial Design Pilot Might Be Handicapped By Disclosure Requirements
FDA wants to publicize some aspects of designs accepted into pilot, which might discourage industry participation.