Category Archives: Policy News

Marcy l’Étoile, France – March 24, 2020 – bioMérieux, a world leader in the field of in vitro diagnostics, today announced that its subsidiary, BioFire Defense, has received Emergency Use Authorization by the U.S. Food and Drug Administration of its BIOFIRE® COVID-19 test for use in CLIA moderate and high complexity clinical laboratories to detect SARS-CoV-2. The BIOFIRE® COVID-19 test detects […]

The General Accounting Office (GAO) has released a report titled, “Antibiotic Resistance: Additional Federal Actions Needed to Better Determine Magnitude and Reduce Impact”. The report was conducted at the request of of the Senate Health, Education, Labor, and Pensions and House Energy and Commerce Committees. GAO was asked to review federal efforts related to (1) […]

Last week, AdvaMed sent a letter to the Office of the United States Trade Representative (USTR), urging that additional tariff exclusions be granted for medical devices, components and supplies coming from China needed in the fight against the COVID-19 pandemic. In the letter to USTR, AdvaMed requested tariff exclusions for more than 80 medical product […]

U.S. Represetatives. Diana DeGette (D-CO) and Fred Upton (R-MI) have announced the concept paper for their bipartisan “Cures 2.0.” The concept paper outlines six key areas of focus for Cures 2.0, which seeks to modernize the delivery of healthcare in the wake of the COVID-19 pandemic.  The six areas of focus are: Public Health Caregiver […]

Summary: This procedure was performed to evaluate the particle penetration and air flow resistance properties of filtration materials. A neutralized, poly-dispersed aerosol of sodium chloride(NaCI) was generated and passed through the test article. The performance of the test article was assessed by measuring the concentration of salt particles penetrating the test article compared to the […]

Connect directly with business and government leaders from the United Arab Emirates in a virtual trade mission hosted by World Trade Center Utah and the U.S.-U.A.E. Business Council. This two-day digital event provides Utah companies with an opportunity to forge strong business ties in the Middle East without leaving home. When you register, you will […]

Thank you for your interest in development of diagnostics for SARS-CoV-2.  On March 30, 2020, the FDA updated the frequently asked questions on diagnostic testing to include new and updated information on:  When FDA authorizes a SARS-CoV-2 test for use at the point of care, does that mean it is CLIA waived? I am developing a […]

Nine rising startup companies from Utah’s growing life sciences industry will present their innovations to investors during the 2020 Entrepreneur & Investor Life Science Summit on February 28, sponsored by Simpson Thacher Salt Lake City, Utah – February 24, 2020 – BioUtah, Utah’s only trade association dedicated solely to the life sciences, in partnership with […]

Utah’s vibrant life sciences industry was on full display yesterday as part of the Governor’s Office of Economic Development’s “Industry Day on the Hill”. The event, held at the state capitol, provided legislators the opportunity to interact one-on-one with company exhibitors from the aerospace, life sciences and tech industries. Representing the life sciences sector were […]

In his State of the Union address February 5, President Trump highlighted a number of health policy goals, including lowering prescription drug prices. Drug pricing continues to be a priority for the Administration and a hot topic of debate for Republicans and Democrats alike. Trump specifically pledged to tackle high drug prices, increase transparency, work […]