July 1, 2022

Ars Technica: FDA calls for fall boosters against BA.4/5 as subvariants take over US

Ars Technica: FDA calls for fall boosters against BA.4/5 as subvariants take over US. “On Thursday, the US Food and Drug Administration advised vaccine makers to reformulate COVID-19 booster shots for this fall. The boosters would target both the original strain of the pandemic coronavirus plus two new omicron subvariants—BA.4 and BA.5—which became the dominant versions of the virus circulating in the United States this week.”

COVID-19 0
June 4, 2022

The Verge: Congress is finally taking medical cybersecurity seriously

The Verge: Congress is finally taking medical cybersecurity seriously. “Years of alarm bells from cybersecurity experts about the vulnerabilities of medical devices are finally being heard by Congress. Senators proposed a new bill this week that would require the Food and Drug Administration to issue cybersecurity guidelines more regularly, and share information about vulnerable devices on its website.”

Security & Legal Issues 0
May 14, 2022

New York Times: Emergent Hid Evidence of Covid Vaccine Problems at Plant, Report Says

New York Times: Emergent Hid Evidence of Covid Vaccine Problems at Plant, Report Says. ” Emergent BioSolutions, a longtime government contractor hired to produce hundreds of millions of coronavirus vaccine doses, hid evidence of quality control problems from Food and Drug Administration inspectors in February 2021 — six weeks before it alerted federal officials that 15 million doses had been contaminated. The disclosure came in a report released Tuesday by House Democrats, who said that all told, nearly 400 million doses of coronavirus vaccine manufactured by Emergent had to be destroyed ‘due to poor quality control.’”

COVID-19 0
April 29, 2022

11 Alive: FDA posts new expiration dates for some at-home COVID tests

11 Alive: FDA posts new expiration dates for some at-home COVID tests. “If you’re planning on using an at-home COVID test, one thing to always consider is the expiration dates. Experts warn that tests used after the expiration date may not provide you with accurate results. But how exactly can you find the expiration dates for FDA-approved at-home testing kits? And is the shelf life the same for different brands of tests?”

COVID-19 0
April 23, 2022

Fauci confirms parents’ nightmare: FDA may delay COVID vaccines for kids under 5 (Ars Technica)

Ars Technica: Fauci confirms parents’ nightmare: FDA may delay COVID vaccines for kids under 5. “The Food and Drug Administration is considering holding off on reviewing Moderna’s COVID-19 vaccine for children under age 5 until it has data from Pfizer and BioNTech on their vaccine for young children. The plan would push back the earliest possible authorization for a vaccine in the age group from May to June—yet another blow to parents who are anxious to protect their young children as the rest of the country ditches pandemic precautions, despite recent upticks in cases.”

COVID-19 0
March 19, 2022

Ars Technica: Please stop putting COVID-19 test solution in your eyes and nose, FDA says

Ars Technica: Please stop putting COVID-19 test solution in your eyes and nose, FDA says. “The Food and Drug Administration is alerting Americans to the potential dangers of at-home COVID-19 tests after receiving reports of people egregiously misusing them, resulting in injuries. In a safety communication released Friday, the FDA said it had received reports of injuries after people used the kits’ liquid test solution as eye drops or stuck the solution up their noses.”

COVID-19 0
March 18, 2022

CNN: Moderna seeks FDA authorization for second Covid-19 booster shot for all adults

CNN: Moderna seeks FDA authorization for second Covid-19 booster shot for all adults. “Moderna announced Thursday that it’s asked the US Food and Drug Administration for authorization for a second Covid-19 booster shot for everyone 18 and older. Moderna is seeking an amendment of the FDA’s emergency use authorization for its Covid-19 vaccine to allow a fourth vaccine dose for any adults who’ve gotten an initial booster of any of the authorized or approved vaccines.”

COVID-19 0
January 25, 2022

Washington Post: FDA ends for now use of two monoclonal antibodies, spurring a halt in federal shipments of the covid-19 treatments

Washington Post: FDA ends for now use of two monoclonal antibodies, spurring a halt in federal shipments of the covid-19 treatments. “The Food and Drug Administration on Monday took two monoclonal antibody therapies off the list of covid-19 treatments for now, saying the medications should not be used anywhere in the United States because they are ineffective against the dominant omicron variant.”

COVID-19 0
January 10, 2022

UPI: FDA warns against using COVID-19 test swabs in the throat

UPI: FDA warns against using COVID-19 test swabs in the throat. “Swabs that come with at-home rapid antigen COVID-19 tests should be used in the nose and not the throat, the U.S. Food and Drug Administration warns. It issued the warning on Twitter in response to reports that some people are using swabs intended for nasal samples to take samples from their throats and posting their results on social media with the hashtag #SwabYourThroat.”

COVID-19 0
January 3, 2022

Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine (PR Newswire)

PR Newswire: Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine. “Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to: * Expand the use of a single booster dose to include use in individuals 12 through 15 years of age. * Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months. * Allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age.”

COVID-19 0

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