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Drugs
Development & Approval Process (Drugs)
How Drugs are Developed and Approved
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Development & Approval Process (Drugs)
How Drugs are Developed and Approved
Drug and Biologic Approval Reports
NDA and BLA Approvals
NME Drug and New Biologic Approvals
ANDA (Generic) Drug Approvals
Priority NDA and BLA Approvals
Efficacy Supplement Approvals
Accelerated and Restricted Approvals
NDA Approvals by Therapeutic Potential and Chemical Type
Fast Track Approval Reports
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NDA and BLA Approvals
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CDER Drug and Biologic Approvals for Calendar Year 2011
(PDF - 227KB)
CDER Drug and Biologic Approvals for Calendar Year 2010
(PDF - 282KB)
CDER Drug and Biologic Approvals for Calendar Year 2009
(PDF - 237KB)
CDER Drug and Biologic Approvals for Calendar Year 2008
(PDF - 92KB)
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