CDER Drug
and Biologic Approval Reports
(CDER biologic approvals beginning in
2004)
Approval Times
New Drug Applications (NDAs) & Biologic License Applications (BLAs)
New Molecular Entity Drugs (NMEs) & New Biologics (New BLAs)
NDA and BLA
Approvals
2009 
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
NME Drug and New Biologic
Approvals
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
Priority NDA and BLA
Approvals
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
Efficacy
Supplement Approvals
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
Accelerated and Restricted
Approvals Under Subpart H (drugs) and Subpart E (biologics)
NDAs, NDA Supplements, BLAs, and BLA Supplements
Fast Track
Reports
Approvals
Statistics (Current Fiscal Year)
Statistics (Fiscal Year 1998-2006)
First Action Performance
Reports ─ Cohort Closeout Statistics (Fiscal Years)
Original NDAs
NDA Resubmissions
Original Efficacy Supplements Efficacy Supplement Resubmissions
Original Manufacturing Supplements
Approval Rates by Cohort
Year of Receipt (Fiscal Years)
CDER Priority NDAs & BLAs
CDER Standard NDAs & BLAs
IND Reports
Active INDs
IND Receipts
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Date updated: December 23, 2008 |
