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PharmaCyte Biotech Receives Medical Devices Registration and Submits Pre-EUA Application to the FDA for COVID-19 Diagnostic Kit
LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer
About this update from Pharmacyte Biotech, Inc.
[{"type":"text","content":" LAGUNA HILLS, Calif.--(BUSINESS WIRE)--\nPharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that it has received Medical Devices Establishment Registration with the FDA’s Center for Devices and Radiological Health (CDRH). The CDRH requires this registration for companies that plan to import medical devices from overseas suppliers. The company also established itself as the sole U.S. agent for Hai Kang Life Corporation Limited (Hai Kang) for the importation of SARS-CoV-2 in vitro diagnostic test kits. The company plans to market its PCR-based diagnostic tests kits to Clinical Laboratory Improvement Amendments (CLIA) certified labs throughout the United States.\n\n\nThe company also announced that it is in dialogue with the U.S. Food and Drug Administration (FDA) through a Pre-Emergency Use Authorization (EUA) submission to the FDA. An EUA is a legal means for the FDA to expeditiously approve new drugs and new medical devices during a declared national emergency. For COVID-19 diagnostic test kits, the FDA recommends that manufacturers and suppliers file a Pre-EUA with the FDA in order to interactively work towards an eventual EUA submission and approval by the FDA. The FDA encourages companies to file an early draft so that the FDA examiner can offer feedback to avoid delays during the review of the final EUA application.\n\n\nKenneth L. Waggoner, the Chief Executive Officer of PharmaCyte Biotech, stated, “We have satisfied all of the regulatory requirements to get our COVID-19 diagnostic test kits into the country and are actively working with our partner, Hai Kang, through the FDA’s preferred process of a Pre-EUA submission, dialoguing with our assigned examiner towards a final EUA submission to and approval by the FDA.”\n\n\nAbout PharmaCyte Biotech \n\n\nPharmaCyte Biotech, Inc. (PharmaCyte) is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. In addition, PharmaCyte is developing and preparing to obtain approv...