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Pioglitazone-containing Medicines: Drug Safety Communication
Includes Actos, Actoplus Met, Actoplus Met XR, Duetact, and Oseni [Posted 12/12/2016] AUDIENCE: Internal Medicine, Endocrinology, Urology ISSUE: As a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder…
Class I Medical Device Recall: Centurion Recalls Multi-Med Single Lumen Catheters due to Excess Material that May Split or Separate
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Emergency Use Authorizations: Zika ELITe MGB® Kit U.S. (ELITechGroup Inc. Molecular Diagnostics)
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…
PMA Final Decisions for November 2016
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150004, DEN150037, DEN150049 added)
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Presentation and Transcript added to Webinar – Final Guidance on Medical Device Reporting for Manufacturers
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MDUFA III Performance Report
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Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids
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A Message from the Director, Division of Mammography Quality Standards (DMQS): EQUIP
First, I want to thank everyone for the very positive feedback we have received about the series of articles on MQSA topics which we launched in 2015. We are glad that you have found them informative and relevant. You can send any suggestions for future topics to [email protected]. As you know, on October 27, 2016,…