NetworkNewsBreaks – Trxade Group, Inc.’s (NASD
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Posted On: 04/01/2020 3:17:27 PM
NetworkNewsBreaks – Trxade Group, Inc.’s (NASDAQ: MEDS) Integra Pharma Solutions Files for FDA Emergency Use Authorization for Rapid COVID-19 Test Kit
Trxade Group, Inc. (NASDAQ: MEDS), an integrated drug procurement, delivery and healthcare platform, today announced that its wholly-owned subsidiary, Integra Pharma Solutions, has filed for an Emergency Use Authorization (“EUA”) with the U.S. Food and Drug Administration (“FDA”) in collaboration with its partnered manufacturer of the SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may, in an emergency, allow unapproved medical products or unapproved uses of approved medical products to be used in the diagnosis, treatment or prevention of serious or life-threatening diseases or when there are no adequate, approved, and available alternatives. The EAU filing has dual purposes; first serving as FDA notification that Trxade Group will be distributing the test and, secondly, if the EUA is approved, it enables Trxade Group to market the product for diagnostic use. Currently, the test is intended to aid in presenting a qualitative overview of antibody presence in patients who have possibly been infected by the Coronavirus (COVID-19).
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
Trxade Group, Inc. (NASDAQ: MEDS), an integrated drug procurement, delivery and healthcare platform, today announced that its wholly-owned subsidiary, Integra Pharma Solutions, has filed for an Emergency Use Authorization (“EUA”) with the U.S. Food and Drug Administration (“FDA”) in collaboration with its partnered manufacturer of the SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may, in an emergency, allow unapproved medical products or unapproved uses of approved medical products to be used in the diagnosis, treatment or prevention of serious or life-threatening diseases or when there are no adequate, approved, and available alternatives. The EAU filing has dual purposes; first serving as FDA notification that Trxade Group will be distributing the test and, secondly, if the EUA is approved, it enables Trxade Group to market the product for diagnostic use. Currently, the test is intended to aid in presenting a qualitative overview of antibody presence in patients who have possibly been infected by the Coronavirus (COVID-19).
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
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