Table 2.

Topics requiring FDA, industry, and academic action

•FDA Topics oGuidance(s) ▪Estimate phase III patient sample‐RWP gap ▪Pivotal clinical study population biomarker sampling (e.g., drug concentration, and PD) ▪Population PK/PD analysis and reporting requirement ▪Drug dose selection assessment supporting RWP dosing recommendations (extremes of size, organ function, age, pregnancy, and genotype) ▪CDS drug dosing software oRWP post‐market efficacy‐safety analysis and reporting ▪Evaluate utility of RWP individual patient drug concentration estimate (population PK, PK/PD) model) to be used in conjunction with routine RWP efficacy‐safety assessment oProvide R&D funding supporting RWP research, CDS tool development, and performance evaluation •Pharmaceutical industry oDetermine incentives if any needed to support precision dosing for all patients oPlan PDUFA VII goals and finance supporting precision dosing oProvide R&D funding supporting RWP research, CDS tool development, and performance evaluation •Academia, clinical professional organizations (e.g., AMA, AHA, IDSA, APA, ACCP, and ASCPT) oPrepare priority lists for drug‐disease targets oProvide CDS drug dosing performance specifications.