The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
FDA Webinar: 60-Day Draft Guidance on Using an Endpoint to Support Accelerated Approval of Drugs to Treat Early-Stage Breast Cancer On Thursday, June 28, 2012, at 2:30 p.m. (ET), FDA will present a webinar to discuss the new draft guidance for industry entitled, “Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use of an Endpoint to Support Accelerated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During this webinar, speakers from FDA's Office of Hematology Oncology Products Breast Oncology Group will discuss the draft guidance, which is intended to assist applicants in designing trials to support marketing approval of drugs to treat breast cancer in the Neoadjuvant (preoperative)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). Information about the draft guidance and webinar can be found at http://www.fda.gov/Drugs/ucm309182.htm Guidance Webinar Online-Access Instructions: To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers. After following the link, enter as a guest and provide your FULL NAME and organization (i.e. "John Smith - FDA/CBER"). The host will then allow you to enter. If you experience technical difficulties email Jeffery.Rexrode@fda.hhs.gov for assistance. Closed captioning will be provided. Questions/Comments can be submitted live via a Q/A chat window. Access link: https://collaboration.fda.gov/guidancewebinars/ If you have never attended a Connect Pro meeting before, please test your connection before the lecture by following this link: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the SBA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM. Please take our CDER Small Business survey: https://www.surveymonkey.com/s/cdersmallbusiness
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