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GUIDANCE DOCUMENT

Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval October 2014

Final

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

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist applicants in designing trials to support marketing approval of drugs and biological products for the treatment of breast cancer in the neoadjuvant (preoperative) setting. The main focus of the guidance is to discuss the use of pathological complete response (pCR) in breast cancer as a potential endpoint to support approval under the accelerated approval regulations (21 CFR part 314, subpart H, for drugs and 21 CFR part 601, subpart E, for biological products).


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.