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FDA Workshop – Seizure Detection, Cognitive Function, and TBI/Concussion Devices: Issues in Their Evaluation, June 2
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Yervoy (ipilimumab): Risk Evaluation and Mitigation Strategy (REMS) – Severe Immune
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PMA Final Decisions for January 2011
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Federal Register: Risk Communication Advisory Committee; Notice of Meeting
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Best Enhancer: Recall – Undeclared Drug Ingredient
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Guidance for Industry and FDA Staff
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Summary Information for: Selenia Dimensions 3D System
Issued February 11, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated March 9, 2011
Consumer Information on: Selenia Dimensions 3D System
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Summary Information for: OraQuick HCV Rapid Antibody Test
Issued February 18, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated March 9, 2011