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Surrogate Endpoints for Breast Cancer Drug Accelerated Approval

05/30/2012

Federal Register Notice: FDA is making available a draft guidance for industry entitled Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval. It is intended to assist applicants in designing trials to support marketing approval of drugs to treat breast cancer in the neoadjuvant (preoperative) setting using pathologic complete response as a surrogate endpoint that could support approval under the accelerated approval regulations. To download this guidance, click here. To view this notice, click here.

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