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Summary Information for: Juvéderm Ultra XC
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Updates to CDRH Customer Service
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Battery CtQ Pilot Report
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FDA-Industry MDUFA IV Reauthorization Meeting, October 1, 2015
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PMA Final Decisions for August 2015
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Added Presentations to Public Workshop – Non
The Food and Drug Administration (FDA) announced a Public Workshop entitled “Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use.” The purpose of this workshop was to receive input from stakeholders and discuss approaches to establish the performance of non-microbial biomarker assays for differentiating viral from bacterial infections and for diagnosis and assessment of sepsis….
CDRH Industry Basics Workshop – Purchasing Controls & Process Validation
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Manufacturing Site Change Supplements: Content and Submission
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Transcript posted for Sept. 24, 2015 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting
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