FDA Webinar: Draft Guidance on Using an Endpoint to Support Accelerated Approval of Early-Stage Breast Cancer Drugs

FDA for Women eblast from the FDA Office of Women's Health FDA for Women  www.fda.gov/womens Free Publications Women's Health Research Women's Health Topics FDAWomen on Twitter FDA Webinar: Draft Guidance on Using an Endpoint to Support Accelerated Approval of Early-Stage Breast Cancer Drugs On Thursday, June 28, 2012, at 2:30 p.m. (ET), FDA will present a webinar to discuss the new draft guidance for industry entitled, Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use of an Endpoint to Support Accelerated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.   During this webinar, speakers from FDA's Office of Hematology Oncology Products Breast Oncology Group will discuss the draft guidance, which is intended to assist applicants in designing trials to support marketing approval of drugs to treat breast cancer in the Neoadjuvant (preoperative)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). This draft guidance was published in the May 30, 2012 Federal Register (FR) under Docket No. FDA 2012 D 0432. To access the draft guidance, visit http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM305501.pdf   FR Notice: http://www.gpo.gov/fdsys/pkg/FR-2012-05-30/pdf/2012-12928.pdf   Information about the draft guidance and webinar can be found at http://www.fda.gov/Drugs/ucm309182.htm Please share this email with your network.

---

Subscriber Services:
Manage Preferences  |  Unsubscribe  |  Help with this service

Stay Connected:

---

This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420