On June 13, the U.S. Food and Drug Administration (FDA) issued the final guidance: Content of Premarket Submissions for Device Software Functions. The final guidance provides information regarding the recommended documentation sponsors should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions. The guidance replaces the FDA’s […]
Yesterday, President Biden signed into law the American Rescue Plan (H.R. 1319), a $1.9 trillion COVID-19 relief package that Congress approved this week. On Wednesday, the House of Representatives approved the Senate-passed version of the bill by a vote of 220 to 211, with one Democrat joining all Republicans in voting against it. Rep. Jared […]
PPP loans have been reopened with an infusion of $284 billion for First Draw and Second Draw loans. First Draw loan applications will be accepted from January 11, 2021 to March 31, 2021. Second Draw applications begin January 13, 2021, until March 31, 2021. To promote access for smaller lenders and their customers, SBA will […]
As reported in last week’s BioUtah News and Events, HHS on Nov. 20 released an interim final rule (IFR) implementing the Most Favored Nation (MFN) Model, a new payment model through the Center for Medicare and Medicaid Innovation (CMMI) that would, starting January 1, base the price Medicare pays for for 50 high-cost Medicare Part […]
The FDA on Nov. 24 posted two templates with recommendations on what to include in EUA requests for serology tests. These templates provide the FDA’s current recommendations on what data and information should be submitted to the FDA in support of an EUA request or Pre-EUA submission for a SARS-CoV-2 antibody test or home specimen […]
Sanofi and the Parkinson’s Foundation announced on Wednesday a new research collaboration to advance the availability of genetic testing and counseling for people with Parkinson’s disease in the U.S. Over the next two years, Sanofi will provide $1 million in research funding to support the PD GENEration Mapping the Future of Parkinson’s Disease initiative. The […]
On October 7, the SBA released updated FAQs (question #52) to clarify that lenders must recognize the extended deferral period for payments on the principal, interest, and fees on all PPP loans, even if the initial loan terms indicates a six-month deferral (the initial period when the program was first enacted). Under the Paycheck Protection […]
Congress recently provided a short-term extension until December 11 of the Rare Pediatric Disease Priority Review Voucher program. The program was set to expire on September 30, but was given a reprieve in the Continuing Appropriations Act, 2021 and Other Extensions Act (H.R. 8337) that kept the government funded. Congress will have to act again […]
BioUtah member Johnson & Johnson (J&J) announced that they’ve started the global phase 3 trial of Janssen’s single-dose vaccine candidate, following phase 1/2 studies that demonstrated safety and immunogenicity. “As COVID-19 continues to impact the daily lives of people around the world, our goal remains the same – leveraging the global reach and scientific innovation […]
During a campaign event yesterday in Charlotte, North Carolina, President Trump signed an executive order on a range of health issues, including protecting people with pre-existing medical conditions, lowering prescription drug costs, increasing consumer choice, and providing greater transparency. The order also directs HHS Secretary Alex Azar to work with Congress to pass legislation to […]
The Administration on Wednesday released a detailed plan for the distribution of free COVID-19 vaccines beginning next year. The plan would prioritze vaccines for healthcare workers, essential employees, and high-risk indiividuals. From there, distribution would be expanded to the broader population. The plan includes two documents: documents: A strategic distribution overview along with an interim […]
At a July 30 White House Roundtable, plasma industry leader and CSL Behring (CSL) CEO Paul Perreault, urged people who have recovered from COVID-19 to consider donating plasma to help develop a potential treatment for people with serious complications from COVID-19. Representing the plasma industry, Perreault pointed to the unprecedented CoVIg-19 Plasma Alliance – an […]