Federal Register Notice: FDA is making available guidance for industry entitled Pathological 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 pathological complete response as a surrogate endpoint that could support approval under the accelerated approval regulations. It finalizes a 5/2012 document. To download this guidance, click here. To view this notice, click here.