CPC Offers Comments on FDA’s Integrated Review Documentation Template

On September 28, 2020, CPC submitted comments on FDA’s “New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation.” While CPC supports the integrated review template and acknowledges the value of implementing a system that effectively communicates the basis for new drug approvals, we are concerned that the proposed integrated review template will lack the level of detail currently provided in the discipline-specific review memos, which our members regularly reference. As such, we strongly recommend that, as FDA implements the integrated review document, the discipline-specific review memos remain publicly available to ensure full transparency and understanding of the Agency’s current thinking with respect to combination product requirements.