FDA Webinar to Discuss 60-Day Draft Guidance on Using an End

[admin]

On Thursday, June 28, 2012, at 2:30PM (ET), FDA will present a webinar to discuss the new draft guidance for industry entitled, “Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use of an Endpoint to Support Accelerated Approval” (http://www.fda.gov/downloads/Drugs/Guid ... 305501.pdf)

This guidance is intended to assist applicants in designing trials to support marketing approval of drugs to treat breast cancer in the Neoadjuvant (preoperative) setting. The main focus of the guidance is to discuss the use of pathologic 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).