The Agency Speaks to Its Effort for Modernizing FDA’s New Drugs Regulatory Program

Today, in the Federal Register (here), the FDA announced a portion of its continuing modernization plan relative to better assessing its summary of approval that FDA prepares for all new NDA and BLA approvals. The notice asked for public comment on “the Clinical Data Summary Report Pilot program as part of the Agency’s continuous assessment of the efficiency and transparency of the clinical data used in the regulatory decision-making process.  The Agency is also seeking public feedback on a new integrated review template for the documentation of new drug marketing applications developed as part of the New Drugs Regulatory Program Modernization.”

In addition, FDA also posted a summary of the modernization process that began in 2017, along with the plans for the long-term continuation of the plan (here).  The Agency indicates that the modernization process focuses on 6 strategic objectives:

  • Scientific Leadership
  • Integrated Assessment
  • Benefit-Risk Monitoring
  • Managing Talent
  • Operational Excellence
  • Knowledge Management

In its announcement, the FDA has provided actual example of its “new integrated review template, which has three main components – an executive summary, an interdisciplinary assessment, and appendices” and rewrote the reviews originally posted for two drug products (Pifeltro and Delstrigo) with links to the new summary for each product as an illustration of the proposed new format.

As the FDA moves forward, they plan to release other updates to this modernization initiative.