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Drugs
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Concept Papers
| Title and Format | Type | Issue Date |
|---|---|---|
|
Animal Models — Essential Elements to Address Efficacy Under the Animal Rule (PDF - 135 KB) |
Draft
|
9/9/2008
|
| PDUFA Pilot Project: Proprietary Name Review (PDF - 295 KB) |
Final
|
10/7/2008
|
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