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Guidance Issuing OfficeCenter 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).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2012-D-0432.