The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
FY2013 GDUFA Performance Report
FDA has met all GDUFA program commitments for FY2013 and laid the foundation for future success. We are committed to meeting all GDUFA performance goals while, as always, maintaining a focus on ensuring that safe, effective, and affordable human generic drugs are reviewed in an efficient and predictable time frame.
FDA has presented the fiscal year (FY) 2013 Generic Drug User Fee Amendments of 2012 (GDUFA) Performance Report to the President and Congress. This performance report covers the period of October 1, 2012, through September 30, 2013, and presents FDA’s accomplishments for the first year of GDUFA and expectations for the future.
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/CDER_Small_Business_Assistance_Evaluation
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