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ProPhase Labs Announces Opening of Large CLIA Lab Covid Testing Facility in Garden City, New York


Press release content from Globe Newswire. The AP news staff was not involved in its creation.
ProPhase Labs Announces Opening of Large CLIA Lab Covid Testing Facility in Garden City, New York
ProPhase Labs, Inc.January 29, 2021 GMT
- Total Company Processing Capacity On Track to Reach 60,000 Tests Per Day –
GARDEN CITY, NY, Jan. 29, 2021 (GLOBE NEWSWIRE) ProPhase Labs, Inc. (NASDAQ: PRPH), a diversified medical science and technology company, announced today the opening of its 25,000 square foot facility in Garden City, New York. The new lab features state-of-the-art technology and offers a wide range of laboratory testing services for diagnosis, screening and evaluation of diseases, including COVID-19 and Respiratory Pathogen Panel Molecular tests. ....

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Quanterix Provides Operational and Preliminary Financial Highlights


Press release content from Business Wire. The AP news staff was not involved in its creation.
Quanterix Provides Operational and Preliminary Financial Highlights
January 13, 2021 GMT
BILLERICA, Mass. (BUSINESS WIRE) Jan 13, 2021
Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, today provided operational and preliminary financial highlights for the fourth quarter and fiscal year ended December 31, 2020.
“While last year brought extraordinary challenges for the world, it also amplified the critical potential of our precision health strategy to address acute issues associated with the spread of COVID-19 virus and longer-term health concerns resulting from the infection,” said Kevin Hrusovsky, Chairman, Chief Executive Officer and President, Quanterix and Founder of Powering Precision Health (PPH). “Our timely pivot to address the pandemic enabled us to keep our employees safe and by ye ....

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Looking Ahead: FDA in 2021


Saturday, January 9, 2021
The U.S. Food and Drug Administration had a busy 2020, as detailed in earlier blog posts. This blog post explores politics and a few policy activities we’ll be keeping an eye on in 2021 and how they might impact medical product manufacturers, particularly now that we know the U.S. Senate will be controlled, like the U.S. House of Representatives and the White House, by Democrats.
Politics
Chairmanship of the powerful House Energy & Commerce Committee, which has jurisdiction over FDA, remains with Rep. Frank Pallone of New Jersey while Senator Patty Murray of Washington is in line to helm the Senate Health, Education, Labor, and Pension (HELP) Committee. While President-elect Joe Biden has announced his picks for Secretary of Health and Human Services (California Attorney General Xavier Beccera) and Director of the Centers for Disease Control and Prevention (Rochelle Walensky, chief of the Infectious Diseases at Massachusetts Gene ....

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Iredell Health Department announces COVID-19 vaccine rollout for health care workers, first responders

Iredell Health Department announces COVID-19 vaccine rollout for health care workers, first responders
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COVID-19 Vaccine: Approval or Authorization? | BakerHostetler


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On Dec. 11, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine for the prevention of the coronavirus disease 2019 (COVID-19).
An EUA differs from an approval in that the statutory standard to receive an EUA is lower than the standard to receive approval. Sponsors may seek approval of medical products at any time. For an EUA, there must be some condition or event to rationalize emergency use of a medical product. Importantly, receiving an EUA does not mean that a product is FDA “approved.” An EUA allows for the temporary marketing of a medical product during an emergency (the COVID-19 public health emergency, in this case). For continued marketing after the COVID-19 public health emergency ends, manufacturers will need to receive a full approval or clearance from the FDA. ....

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