The U.S. Food and Drug Administration (FDA) has asked Philips to conduct more tests on the foam used in its recalled ventilators, after the agency found several new issues at the Dutch company’s manufacturing facility. The medical equipment company recalled some breathing devices and ventilators in June because of a silicone-based foam part that might…
Biden to Nominate Robert Califf as FDA Commissioner
President Joe Biden on Friday announced that he will nominate former Food and Drug Administration (FDA) Commissioner Dr. Robert Califf to once again head the agency. Califf, who was commissioner for nearly a year starting in February 2016, “is one of the most experienced clinical trialists in the country, and has the experience and expertise…
FDA Alert: 2 Million At-home COVID-19 Tests Recalled Over False Positives
The U.S. Food and Drug Administration (FDA) confirmed Thursday it is recalling some 2 million Ellume at-home COVID-19 testing because they can produce “false positives” due to a manufacturing defect. The firm first informed the federal regulatory agency about the defect in some lots in October. But on Wednesday, the FDA said it identified additional…
Vaccine Mandates Make Cities Unsafe and Hurt Private Business
It was anticipated that once vaccines passed FDA approval, vaccine mandates would follow, and I examine the effect this is having on workers in the critical civil service sector, such as on policemen, firefighters, and military—some of whom have legitimate reasons for not wanting to take the vaccine, which underscores the issue of medical freedom….
Pfizer Board Member: Pandemic Could Be Over in US by January
Former Food and Drug Administration (FDA) commissioner and current Pfizer board member Scott Gottlieb said he believes the COVID-19 pandemic in the United States could be over by January 2022. “I think the bottom line though is that these mandates that are going to be put in place by Jan. 4 really are coming on…
Rep. Murphy: FDA Adviser’s Remark on COVID-19 Jab for Kids ‘The Most Dangerous Statement I’ve Ever Heard in Medicine’
October 30, 2021
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A remark made by a Food and Drug Administration (FDA) adviser is “the most dangerous statement I’ve ever heard in medicine,” the only active practicing physician in Congress said in a new interview. Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine, and an associate physician specializing in infectious disease at Brigham and…
Kids and Vaccines: After FDA’s Emergency Authorization, a Look at the Evidence
News Analysis To read the headlines, you’d think the verdict was in. On Oct. 26, the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee recommended the approval of Pfizer-BioNTech’s RNA COVID-19 vaccine for children 5-11, under an Emergency Use Authorization (EUA). On Oct. 29, the FDA issued an emergency authorization based…
FDA Authorizes Pfizer COVID-19 for Emergency Use in Children Aged 5 to 11
The Food and Drug Administration (FDA) on Friday issued an emergency authorization to use Pfizer’s COVID-19 vaccine in children aged 5 through 11, coming days after an advisory panel recommended it. But before the shots can be distributed across the United States, the Centers for Disease Control and Prevention (CDC) must first sign off on…
FDA Authorizes Pfizer COVID-19 Vaccine for Emergency Use in Children Aged 5 to 11
The Food and Drug Administration (FDA) on Friday issued an emergency authorization to use Pfizer’s COVID-19 vaccine in children aged 5 through 11, coming days after an advisory panel recommended it. But before the shots can be distributed across the United States, the Centers for Disease Control and Prevention (CDC) must first sign off on…
Biden Administration Purchases 50 Million More Vaccine Doses for Kids, Pfizer Says
October 29, 2021
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The Biden administration has purchased an additional 50 million Pfizer-BioNTech COVID-19 vaccine doses for children to be delivered by the end of April next year, the drugmakers said in a statement on Thursday. “The U.S. will receive these additional doses to continue to support preparedness for pediatric vaccinations, including securing vaccines for children under 5…
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