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The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry
FDA Announces Fiscal Year 2015 Generic Drug User Fee Rates
Today the FDA published the fiscal year 2015 generic drug user fee rates as required under the Food Drug and Cosmetic Act as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA). This announcement includes the rate for the abbreviated new drug application (ANDA), prior approval supplement to an approved ANDA (PAS), drug master file (DMF), active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees.
GDUFA authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on certain generic FDF and API facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference for generic applications.
These fees are effective on October 1, 2014, and will remain in effect through September 30, 2015.
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.
- Email: CDERSBIA@fda.hhs.gov
- Phone: 1-866-405-5367
- Phone: (301) 796-6707
- Website: http://www.fda.gov/cdersbia
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