For Industry
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Additional Information (PDUFA)
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Important Information About Products Covered by PDUFA
User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act
List of billable products - CBER- CDER Billable Products List - March 2012 (PDF - 88KB)
List of billable products - CDER PDUFA Documents - Pediatric Exception Repealed
Important notice - pediatric supplements no longer exempt from fees (1/8/2002)
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Additional Resources
CDER Small Business Webinar on PDUFA - December 19, 2011
Provides an overview of PDUFA
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