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Product 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 - September 2009 (PDF - 40KB)
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PDUFA Documents - Pediatric Exception Repealed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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