February 27, 2021

CNET: FDA panel gives Johnson & Johnson’s one-shot COVID-19 vaccine green light

CNET: FDA panel gives Johnson & Johnson’s one-shot COVID-19 vaccine green light. “An advisory panel for the US Food and Drug Administration has recommended Johnson & Johnson’s single-dose COVID-19 vaccine be given the green light by the FDA. The FDA Vaccines and Related Biological Products Advisory Committee unanimously voted Friday afternoon to approve the vaccine. The next step will be emergency approval from the FDA itself.”

COVID-19 0
February 2, 2021

HealthImaging: New database of FDA-cleared algorithms helps radiologists quickly navigate complex AI environment

HealthImaging: New database of FDA-cleared algorithms helps radiologists quickly navigate complex AI environment. “The American College of Radiology on Monday announced a new, searchable database of federally cleared algorithms to help radiologists navigate the complex artificial intelligence environment. The ACR Data Science Institute’s catalog includes 111 class 2 medical imaging AI algorithms cleared by the U.S. Food & Drug Administration. Radiologists can search for tools according to company, subspeciality, body area, modality, and clearance date to find what may best fit their clinical needs.”

Research & Opinion 0
December 20, 2020

CNN: FDA authorizes first over-the-counter, non-prescription Covid-19 test system for home use

CNN: FDA authorizes first over-the-counter, non-prescription Covid-19 test system for home use. “The US Food and Drug Administration has granted an emergency use authorization for the first non-prescription, over-the-counter Covid-19 test kit for at-home use. The LabCorp Pixel COVID-19 Test Home Collection Kit allows anyone 18 and older to buy the kit and collect nasal swab samples at home, the FDA said in a news release Wednesday. The samples are then sent to a LabCorp facility for testing.”

COVID-19 0
December 18, 2020

Covid: Moderna vaccine moves closer to US approval (BBC)

BBC: Covid: Moderna vaccine moves closer to US approval. “A second coronavirus vaccine is nearing emergency approval in the US after it was endorsed by a panel of experts. The head of the Food and Drug Administration (FDA) said his agency would move quickly to authorise the Moderna vaccine, allowing the company to begin shipping millions of doses.”

COVID-19 0
December 15, 2020

BBC: Moderna vaccine safe and effective, say US experts

BBC: Moderna vaccine safe and effective, say US experts. “Moderna’s vaccine is safe and 94% effective, regulators say, clearing the way for US emergency authorisation. The analysis by the Food and Drug Administration’s (FDA) means it could become the second coronavirus vaccine to be allowed in the US. It comes one day after Americans across the country began receiving jabs of the Pfizer-BioNTech vaccine.”

COVID-19 0
November 20, 2020

FDA: FDA Releases New Outbreak Investigation Table

FDA: FDA Releases New Outbreak Investigation Table. “The U.S. Food and Drug Administration is committed to transparency and keeping the public and stakeholders informed of our work upholding the safety of our food supply. As part of this continued commitment, today we are releasing a new tool to communicate foodborne illness outbreak information frequently and as soon as the FDA begins an outbreak investigation – prior to a public health advisory or recall of a certain food product being issued.”

Tweaks & Updates 0
November 17, 2020

MIT Technology Review: Covid-19 vaccines shouldn’t get emergency-use authorization

MIT Technology Review: Covid-19 vaccines shouldn’t get emergency-use authorization. “I really want a covid-19 vaccine. Like many Americans, I have family members and neighbors who have been sickened and killed by the new coronavirus. My sister is a nurse on a covid-19 ward, and I want her to be able to do her job safely. As a health-care lawyer, I have the utmost confidence in the career scientists at the US Food and Drug Administration who would ultimately determine whether to issue an emergency-use authorization for a covid-19 vaccine. But I am deeply worried about what could happen if they do.”

COVID-19 0
November 1, 2020

Trump’s Vaccine Rush vs. the FDA: Inside Stephen Hahn’s “Existential Crisis” (Vanity Fair)

Vanity Fair: Trump’s Vaccine Rush vs. the FDA: Inside Stephen Hahn’s “Existential Crisis”. “In the last few months, as the president and his surrogates have pressed for speed, the FDA’s career scientists have battled back, using abstruse FDA guidances to pharmaceutical companies and acronym-laden advisory committees to build a bulwark against political interference. Their efforts to increase transparency and guarantee safety have tacked several months onto the accelerated timetable. They understand that the stakes could not be higher, as the agency’s actions in the coming weeks will undoubtedly have a global impact.”

COVID-19 0
October 26, 2020

Los Angeles Times: Newsom says California will review FDA-approved COVID-19 vaccines before releasing them to public

Los Angeles Times: Newsom says California will review FDA-approved COVID-19 vaccines before releasing them to public. “Gov. Gavin Newsom said [October 19] that California will review the safety of all COVID-19 vaccines that receive federal approval before distributing them to the public, adding an extra safeguard amid concerns that the White House could rush the process.”

COVID-19 0
September 30, 2020

Illinois Newsroom: The University Of Illinois Dials Back Statements About FDA Authorization For Its COVID-19 Test

Illinois Newsroom: The University Of Illinois Dials Back Statements About FDA Authorization For Its COVID-19 Test. “On Aug. 19, campus officials announced in a press release that the U of I had begun performing its saliva-based test under the umbrella of an approved FDA emergency use authorization. Illinois Gov. J.B. Pritzker held a press conference that same day to share the news. But in response to questions from Illinois Newsroom about the EUA status of U of I’s saliva test, an FDA spokesperson said in an email: ‘The University of Illinois is not authorized under an umbrella EUA, and they have not had an EUA.’”

COVID-19 0
September 25, 2020

ABC 13: FDA warns about ‘Benadryl Challenge’ after reports of teens ending up in ER

ABC 13: FDA warns about ‘Benadryl Challenge’ after reports of teens ending up in ER. “The craze on TikTok reportedly encourages viewers to take large doses of the antihistamine to induce hallucinations. But the FDA warns that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine can lead to serious heart problems, seizures, coma, or even death.” Apparently this has already killed somebody.

Security & Legal Issues 0
September 24, 2020

New Study: The State Of A.I.-Based, FDA-approved Medical Devices And Algorithms – An Online Database (The Medical Futurist)

The Medical Futurist: New Study: The State Of A.I.-Based, FDA-approved Medical Devices And Algorithms – An Online Database. “The latest peer-reviewed paper from The Medical Futurist Institute (TMFI) analysed the state of regulation over A.I.-based algorithms. Using the FDA as an example, the authors even pioneered the first open access, online database of FDA-approved A.I.-based algorithms, which the U.S.-based regulatory body should have come up with already.” TIL I like a little shade with my open-access databases….

New Resources 0

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