MedMira Inc V.MIR

Alternate Symbol(s): MMIRF

Healthcare Medical Devices

MedMira Inc. is a Canada-based biotechnology company. The Company, through its subsidiaries, is engaged in the business of research, development and manufacturing of rapid diagnostics and technologies. The Company invests in research in order to maintain and expand its position in the global diagnostics market. Its research is focused on specific areas of the broader diagnostics market, namely the rapid, point-of-care, and in vitro sectors. The Company is the developer and owner of Rapid Vertical Flow (RVF) Technology. The Company's rapid test applications built on RVF Technology provide hospitals, labs, clinics and individuals with instant diagnosis for diseases such as Human Immunodeficiency Virus (HIV), Syphilis and hepatitis C in just three easy steps. The Company's tests are sold under the Reveal, Multiplo and Miriad brands in global markets. The Company's manufacturing facilities are located in Halifax, Nova Scotia, Canada.

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Post by zoe18on Jun 27, 2020 11:36am

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Post# 31198684

FDA still updates template to facilitate submission of EUA

June 26, 2020

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

As part of FDA’s effort to protect consumers, the agency issued a warning letter to one company for selling fraudulent COVID-19 products. The company, Curativa Bay Corporation, offers Hypochlorous Skin Spray, a topical hypochlorous acid-containing product for sale in the United States with misleading claims that the product can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
FDA updated the templates for laboratories and commercial manufacturers to help facilitate submission of Emergency Use Authorization (EUA) requests for serology tests. The updates clarify FDA’s previous recommendations for demonstrating clinical performance and presenting validation data; the updates also provide new recommendations for validation of point-of-care tests.
Testing updates:
- To date, there are 153 currently authorized tests under EUAs; these include 129 molecular tests, 23 antibody tests, and 1 antigen test.