Federal News
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FDA Issues Final Guidance on Content of Premarket Submissions for Device Software Functions
On June 13, the U.S. Food and Drug Administration (FDA) issued the final guidance: Content of Premarket Submissions…
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President Biden Signs $1.9 Trillion COVID-19 Relief Bill
Yesterday, President Biden signed into law the American Rescue Plan (H.R. 1319), a $1.9 trillion COVID-19 relief package…
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PPP2 Loans Are Now Open
PPP loans have been reopened with an infusion of $284 billion for First Draw and Second Draw loans.…
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Most Favored Nation Rule Poses Patient Access Issues, Faces Legal Challenges
As reported in last week’s BioUtah News and Events, HHS on Nov. 20 released an interim final rule…
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FDA Posts Serology Templates for Test Developers
The FDA on Nov. 24 posted two templates with recommendations on what to include in EUA requests for…
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Sanofi Commits $1M to Support Parkinson’s Disease Genetic Research
Sanofi and the Parkinson’s Foundation announced on Wednesday a new research collaboration to advance the availability of genetic…
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SBA Extends PPP Loan Deferral, New Streamlined Forgiveness for Loans of $50,000 or Less
On October 7, the SBA released updated FAQs (question #52) to clarify that lenders must recognize the extended…
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Pediatric Rare Disease Voucher Program Extended
Congress recently provided a short-term extension until December 11 of the Rare Pediatric Disease Priority Review Voucher program.…
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J&J Enters Phase 3 Trial for COVID-19 Vaccine
BioUtah member Johnson & Johnson (J&J) announced that they’ve started the global phase 3 trial of Janssen’s single-dose…
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President Trump Signs Executive Order on Healthcare, Pre-existing Conditions
During a campaign event yesterday in Charlotte, North Carolina, President Trump signed an executive order on a range…
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Trump Administration Releases COVID-19 Vaccine Distribution Strategy
The Administration on Wednesday released a detailed plan for the distribution of free COVID-19 vaccines beginning next year.…
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At White House Roundtable, CSL Behring CEO Paul Perreault Urges Plasma Donations to Fight COVID-19
At a July 30 White House Roundtable, plasma industry leader and CSL Behring (CSL) CEO Paul Perreault, urged…
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