The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business

'GDUFA and You Conference' – Registration now OPEN The Generic Drug User Fee Amendments of 2012 (GDUFA) is landmark drug legislation We invite you to attend a conference dedicated entirely to GDUFA. Come and interact with FDA subject matter experts as we discuss various regulatory elements of GDUFA. This is a must attend event for anyone involved with generic drugs. What: GDUFA and You Conference Registration is now open. Please find updated details and registration information on our Conference webpage.
designed to speed the delivery of safe, high-quality, and affordable generic drugs
to the public and reduce costs to industry.
When: June 12-13, 2013
Where: Sheraton Silver Spring Hotel, 8777 Georgia Avenue, Silver Spring. MD 20910
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

