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Summary Basis of Information – NDA #011459 (Comprehensive Review Documents)
Summary Basis of Information – NDA #011459 (Comprehensive Review Documents)
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Request Contents: Summary Basis of Information documents for NDA #011459, including Medical Reviews, Chemistry Reviews, Pharmacology Reviews, Statistical Reviews, Non-Clinical Reviews, Clinical Pharmacology Biopharmaceutics Reviews, Risk Assessment and Mitigation Reviews, Summary Review, Cross-Discipline Team Leader Review, Administrative Documents, Correspondence, and Post-Marketing Reviews.
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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