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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Senate Republicans Release HEALS Act – COVID-19 Stimulus Package
Earlier this week, Senate Majority Leader Mitch McConnell released the Republican version of a fourth COVID-19 package (or…
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President Trump Signs Drug Pricing Executive Orders, Touts “Most Favored Nation” Pricing
Last Friday, President Trump signed four executive orders aimed at lowering drug prices, including an order that would…
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Pfizer and BionTech Announce Agreement with U.S. Government for Up to 600 million doses of COVID-19 Vaccine Candidate
On July 22, Pfizer and BioNTech announced the execution of an agreement with the HHS and DOD to…
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White House, GOP Deal on $1T COVID-19 Relief Package Takes Shape
As reported by The Hill, “White House and Senate Republicans on Thursday reached a “fundamental agreement” on a…
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President Trump to Sign Executive Orders to Lower Drug Prices
While the drug pricing issue has been sidelined amid the COVID-19 pandemic, President Trump is now returning to…
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Sens. Warren, Sanders Slam Gilead Deal with Government while New Research Says Americans Don’t Pay Twice for Drugs
This week Sens. Elizabeth Warren and Bernie Sanders sent a letter to HHS Secretary Alex Azar seeking an…
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Initial Data for Moderna COVID-19 Vaccine Shows Promise
On Tuesday, Moderna announced promising results from the Phase 1 study of its vaccine candidate, called mRNA-1273. The…
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BioFire Respiratory Panel with COVID Target Scores CE Mark
BioMerieux announced that Utah-based BioFire’s Respiratory Panel 2.1 plus, which tests for SARS-CoV-2 and 23 pathogens encompassing 19…
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PhotoPharmics Stay-At-Home Trial for People with Parkinson’s
This week, PhotoPharmics announced a collaboration with the Center for Health + Technology (CHeT) at the University of…
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Johnson & Johnson to Begin COVID-19 Vaccine Clinical Trials in Humans Next Week
Last month, Johnson & Johnson (J&J) announced that its Phase 1/2a in-human clinical trial of its potential COVID-19…
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Pfizer, BioNTech Get FDA Fast Track Status for COVID-19 Vaccines
U.S. Pfizer and Germany’s BioNTech announced Monday that they have received Fast Track designation from the FDA for…
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Changes to PPP Rules Set After Senate Passes Paycheck Protection Flexibility Act of 2020
By Brandon Allfrey, Partner, Squire, Brandona@squire.com Late Wednesday evening, the U.S Senate passed by unanimous consent the Paycheck Protection Program…
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House Democrats Move to Pass $3 Trillion COVID-19 Relief Package
House Democrats have proposed a new $3 trillion relief package, titled the Health and Economic Recovery Omnibus Emergency…
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Coronavirus (COVID-19) Update: FDA updates on surveillance inspections during COVID-19
For Immediate Release: May 11, 2020 Statement From: Commissioner of Food and Drugs – Food and Drug Administran…
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FDA Requires Review of COVID-19 Antibody Tests
To ensure the accuracy of COVID-19 antibody tests and guard against fraudulent testing claims, the FDA recently announced…
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Senate Democrats Announce Legislation to Federalize Medical Supply Chain
Senate Democrats, led by U.S. Senators Tammy Baldwin (D-WI) and Chris Murphy (D-CT), have announced legislation, The Medical Supply, Transparency…
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Congress Approves New $484 Billion COVID-19 Relief Bill, More Funding for PPP
A fourth “interim” bipartisan relief package, the Paycheck Protection Program and Health Care Enhancement Act (H.R. 266), totaling…
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Paycheck Protection Program Has Bumpy Start
The Paycheck Protection Program (PPP) went live April 3, but the process hasn’t gone as smoothly as hoped.…
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National Institutes of Health Accepts Late Grant Applications Given COVID-19 Emergency
On March 26, NIH announced that grant applications submitted late would continue to be accepted recognizing that the…
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Paycheck Protection Program Loans Move Forward SBA/Treasury Department Issue Guidance
On March 31, the Treasury Department and Small Business Administration (SBA) released initial guidance and a sample application…
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CARES Act Includes Rep. Curtis’ small business Advance Payment for Paid Leave
On March 20, after passage of the Families First Coronavirus Response Act (FFCR), Representative John Curtis (R-UT), sent…
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CISA: Advisory Memorandum on Identification of Essential Critical Infrastructure Workers During COVID-19 Response
“As the Nation comes together to slow the spread of COVID-19, on March 16th the President issued updated…
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House Sends $2.2 Trillion Coronavirus Relief Bill to President’s Desk
Today, the U.S. House of Representatives passed H.R. 758, the Coronavirus Aid, Relief and Economic Security Act –…
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Senate aims to vote Wednesday on $2T coronavirus bill
Washington Post – The Senate is aiming to vote Wednesday on a $2 trillion stimulus package that is…
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Romney Announces Resource to Keep Utahns Informed on Coronavirus
WASHINGTON—U.S. Senator Mitt Romney (R-UT) today announced the launch of a new webpage designed to keep Utahns informed…
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Rep. Curtis Sends Letter to Treasury Department Advocating for Small Business Relief
FOR IMMEDIATE RELEASE: March 20, 2020 Media Contact: Ally Riding (202) 226-7721 Washington, DC— Today, Representative John…
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SEC adopts McAdams and Hollingsworth proposal to cut red tape on promising start-ups
Courtesy of mcadams.house.gov Washington, D.C.—Legislation by Congressman Ben McAdams and Congressman Trey Hollingsworth (R-IN) giving commonsense regulatory relief…
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H.R. 6201, the Families First Coronavirus Response Act Passed by the House 363-40 (3/14/2020)
Article courtesy of the National Association of Manufacturers Emergency Family and Medical Leave Expansion and Paid Sick Leave:…
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