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Guidance Documents/Guidance-Document/Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval

Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

July 29, 2020

July 29, 2020

Center for Drug Evaluation and Research

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