NuGen M.D. Submits for FDA Emergency Use Authorization Approval for its Needle-Free Injection Systems

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[{"type":"text","content":"NuGen M.D. Submits for FDA Emergency Use Authorization Approval for its Needle-Free Injection SystemsVANCOUVER, BC / ACCESSWIRE / June 15, 2022 / NuGen Medical Devices Inc. (TSXV:NGMD) (\"NuGen'' or the \"Company\"), a leader in needle-free drug delivery, in collaboration with Unifire Inc., a wholly owned subsidiary of Mission Ready Solutions (TSXV: MRS, OTCQX:MSNVF) submitted on June14th, 2022, an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (\"EUA\") of NuGen reusable needle-free jet injector (NFJI) systems. NuGen MD NFJI devices are designed for patients and/or healthcare providers for the delivery of insulin, vaccines (potentially including COVID-19 vaccines), and emergency pharmaceutical injectables.The U.S. government released its \"National Strategy for a Resilient Public Health Supply Chain in July 2021\", which outlines the government's plan to respond to disruptions in the supply chain that came as a result of the COVID-19 pandemic. According to the report, there remains much to be done to ensure that the public health supply chain is prepared for future disruptions.Nugen's needle-free injection systems can help address supply chain shortages, while eliminating risks to healthcare personnel of needle stick injuries (NSIs). NSIs have been further exacerbated by the COVID-19 pandemic, as explained by the Centers for Disease Control (CDC).NuGen and Unifire intend this EUA application to act in response to the U.S. government's Request for Information (RFI) released May 20, 2022, as well as current medical supply chain shortages and syringe shortages in crisis-affected areas around the world.The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation's public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate. FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditi...

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