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CPC Comments on FDA’s “New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication”

On August 26, 2019, the CPC filed a comment letter regarding FDA’s “New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication,” and specifically, the proposed new integrated review template. While the CPC supports the integrated review template and acknowledges the value of implementing a system that effectively communicates the basis for new drug approvals, CPC is concerned that the proposed integrated review template will lack the level of detail currently provided in the discipline-specific review memos.  CPC strongly requests 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.