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With subject matter experts from the American Academy of Pediatrics, the CDC is offering a webinar on 2019-2020 Recommendations for Influenza Prevention and Treatment in Children. The webinar is September 26 at 2-3 pm Eastern time. Free continuing education is available. Register for the webinar.
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The FDA issued a warning letter to Innovative Sterilizations Technologies, LLC (IST), for marketing the One Tray® Sealed Sterilization Container for different intended uses outside of its original clearance. FDA claims that One Tray was approved to hold reusable medical devices while they are flash sterilized for immediate use, but the product is being marketed for terminal sterile storage and terminal sterile storage with retained moisture. IST issued a statement on August 22 disputing FDA’s assertions, and claiming that One Tray’s currently marketed indication for use are within the scope of FDA’s original clearance. Read the FDA warning letter and IST’s response statement.
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The HHS Office of the Assistant Secretary for Preparedness and Response, in cooperation with the CDC, Environmental Protection Agency, and the Departments of Transportation, Labor, and Defense issued updated guidance on managing solid waste contaminated with a Category A infectious substance. A Category A substance is capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals. Read the updated guidance document.
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The FDA announced revocation of the Emergency Use Authorization for the xMAP MultiFLEX Zika RNA Assay at the request of the manufacturer, Luminex Corporation, following Luminex’s decision to discontinue the product. Read the FDA notice and Luminex request letter.
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KRS Global Biotechnology, Inc. is voluntarily recalling all lots of unexpired human and animal drugs intended to be sterile. The products are being recalled due to lack of assurance of sterility. Read FDA Alert for more information and list of recalled products.
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Darmerica is voluntarily recalling two lots of Quinacrine Dihydrochloride, bulk API powder packaged in Amber HDPE Bottles because testing revealed that due to a labeling error, the contents of these bottles was a different product. The recalled Quinacrine Dihydrochloride was distributed Nationwide to 14 Compounding Pharmacies. Read the FDA safety alert.
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KRS Global Biotechnology, Inc. is voluntarily recalling all lots of unexpired human and animal drugs intended to be sterile. The products are being recalled due to lack of assurance of sterility. Read FDA Alert for more information and list of recalled products.
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On October 2, the National Center for Immunization and Respiratory Diseases, Immunization Services Division (ISD) will host the second “Current Issues in Immunization” webinar. Dr. Lisa Grohskopf, MD, MPH, will give an update on the recommendations for the 2019–20 influenza season. A question and answer chat box will be available for questions. Click here to learn more.
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Hospira, Inc. is voluntarily recalling Bacteriostatic Water for Injection, USP, 30 mL multidose vial, due to lack of confirmation of sterilization for some vials. The product is indicated only for diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injection. Read the FDA safety alert.
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The U.S. Food and Drug Administration today approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia. Xenleta received FDA’s Qualified Infectious Disease Product (QIDP) designation. The QIDP designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. As part of QIDP designation, Xenleta was granted Priority Review under which the FDA’s goal is to take action on an application within an expedited time frame. Learn more.
