Health News Med: CDER Small Business Update: FY2014 reporting period for Self-Identification under GDUFA

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FY2014 reporting period for Self-Identification under GDUFA

On April 15, 2013, the U.S. Food and Drug Administration published a Federal Register notice announcing the fiscal year (FY) 2014 reporting period (May 1, 2013 -- June 1, 2013) for self-identification of generic drug facilities, sites and organizations. Under GDUFA, human generic drug facilities, sites and organizations are required to submit, update, or reconfirm their identification information annually.

This notice specifies the FY 2014 reporting period from May 1, 2013 - June 1, 2013; the second year that self-identification is required. It summarizes the requirement and refers readers to additional information on FDA’s GDUFA web page (www.fda.gov/gdufa) including who is required to self-identify, the type of information required, the format for submission, and the penalty for failing to comply. The notice can be found at: http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm313983.htm.

Questions about GDUFA can be sent to AskGDUFA@fda.hhs.gov or (866)-405-5367.

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.

Email: CDERSmallBusiness@fda.hhs.gov
Phone: 1-866-405-5367
Phone: (301) 796-6707
Website: http://www.fda.gov/smallbusinessdrugs
Widget: http://www.fda.gov/Drugs/ucm153379.htm

Please take our CDER Small Business survey: https://www.surveymonkey.com/s/cdersmallbusiness

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