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Lamotrigine Orally Disintegrating Tablet 200 mg by Impax: Recall
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Dietary Supplements by Ton Shen Health/Life Rising: Recall
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Emergency Use Authorization – LightMix® Zika rRT
On February 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention’s (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside…
Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices
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Executive Summary posted for September 20-21, 2016 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting
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FDA-Industry MDUFA IV Reauthorization Meeting Minutes, August 15, 2016
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FDA-Industry MDUFA IV Reauthorization Meeting Minutes, July 26, 2016
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Presentation and Transcript added to Webinar – Draft Guidance on Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
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Programmable Syringe Pumps: FDA Safety Communication
[Posted 08/25/2016] AUDIENCE: Nursing, Pediatrics, Pharmacy, Critical Care Medicine ISSUE: The FDA is informing health care professionals that when using programmable syringe pumps to infuse therapies at low rates (e.g., less than 5 mL per hour, and especially at flow rates of less than 0.5 mL per hour), a lack of flow continuity (i.e., inconsistent…