Category: Regulatory Science

Regulatory Authorities Support First Drug Development Tool, Critical to Advance TB R&D Efforts

The first nonclinical drug development tools (DDTs), developed by working groups within CPTR, have been endorsed by leading global regulatory authorities. DDTs with demonstrated predictive accuracy for clinical and microbial outcomes are needed to support effective regimenĀ development decision-making. Endorsement of these DDTs by regulatory authorities is critical for drug developers as it promotes confidence in […]

March 19, 2015 Drug Development Regulatory Science clinical trials hollow fiber model