FDA develops research agenda


The report outlines seven categories: 

• Improve access to post-market data sources and explore feasibility of their use in different types of analyses; 

• Improve risk assessment and management strategies to reinforce the safe use of drugs; 

• Evaluate the effectiveness and impact of different types of regulatory communications to the public and other stakeholders;

• Evaluate the link among product quality attributes, manufacturing processes and product performance;

• Develop and improve predictive models of safety and efficacy in humans;

• Improve clinical trial design, analysis and conduct; and

• Enhance individualization of patient treatment.