Mr. Michael Wright reports
NUGEN M.D. SUBMITS FOR FDA EMERGENCY USE AUTHORIZATION APPROVAL FOR ITS NEEDLE-FREE INJECTION SYSTEMS
Nugen Medical Devices Inc., in collaboration with Unifire Inc., a wholly owned subsidiary of Mission Ready Solutions Inc., submitted on June 14, 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's NFJI devices are designed for patients and/or health care 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 health care personnel of needle stick injuries (NSIs). NSIs have been further exacerbated by the COVID-19 pandemic, as explained by the Centers for Disease Control and Prevention (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 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, when the Secretary of the Department of Health and Human Services declares that an emergency use authorization is appropriate. The 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 conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved and available alternatives.
Additionally, President Joe Biden's remarks in his first-ever State of the Union Address on the diabetes pandemic and the financial strain it puts on the health care system and families living with diabetes. According to the report, preparedness is the key to overcoming supply chain issues.
Nugen's needle-free injection system addresses the public health supply chain by offering an alternative to traditional hypodermic needles, which are single use, pose safety issues if not sanitized or used correctly, and require a strict protocol for collecting and eliminating.
About Nugen Medical Devices Inc.
Nugen's principal business is the development and commercialization of innovative needle-free injection devices and systems for the administration of subcutaneous medication.
It is developing products using needle-free drug delivery technology in several important fields, including, but not limited to, anaphylaxis, diabetes, severe migraine, erectile dysfunction, chronic anemia, neutropenia, autoimmune rheumatoid arthritis, growth and fertility hormone, psoriasis, as well as DNA and conventional/pediatric vaccines.
We seek Safe Harbor.
© 2022 Canjex Publishing Ltd. All rights reserved.