lunes, 28 de abril de 2014

CDER SBIA Update: GDUFA FY 2015 Self-Identification Period

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The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry
FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

GDUFA FY 2015 Self-Identification Period
Generic Drug User Fee Amendments of 2012 (GDUFA) requires that generic drug facilities, and certain sites and organizations identified in a generic drug submission to submit, update, or reconfirm identification information to the Food and Drug Administration (FDA) annually.  For fiscal year 2015 self-identification reporting period will begin on May 1, 2014, and close June 1, 2014. 21 (U.S.C. § 379j–42(f)(2)(B)).
Please note that registration and listing under section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360) is a different process than self-identification under GDUFA. Many persons will thus be required to submit information separately to the respective systems. Each system populates its own database to meet unique requirements and deadlines. Both, however, are built on the same platform and based on the same technical standards. 
Additional information including who is required to self-identify, how the information is submitted to FDA, the penalty for failure to self-identify, and the technical specifications are available at the following url:
If you need further technical assistant with self-identification process, please contact  For general questions about GDUFA self-identification requirements, please contact
Additional resources are available at:
Background information is available at  Staff is available at 866-405-5367 or at to answer any questions. 
Interested parties can register to receive email updates about GDUFA at

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry 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 CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.
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