FDA
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While many across the United States have been patiently waiting for FDA’s approval for the Pfizer-BioNTech COVID-19 vaccine for young children ages 6 months through 4 years of age, it looks like we will have to wait a bit longer. It is unclear how long this will be postponed, but the FDA said that Pfizer […]
Earlier this week, Pfizer and its partner BioNTech applied for authorization for a two-dose regimen at the FDA’s request, even though officials announced in December that two shots did not produce a sufficient immune response in children ages 2 to 4. However, there are trials still underway for a third dose, but data will not […]
The FDA has issued a warning and recalled two COVID-19 test kits. The US Food and Drug Administration recalled the two tests manufactured by Empowered Diagnostics. The two tests recalled CovClear COVID-19 Antigen and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. The FDA recalled the tests because they have the potential for false results. This is […]
After more than 70 years of regulation, the federal government has decided that French dressing no longer needs to be regulated. The FDA stated: “When the standard of identity was established in 1950, French dressing was one of three types of dressings we identified.” According to the FDA, French dressing was the only pourable dressing […]
A new way to help combat COVID-19 has been created and it comes in a form of a pill. Yesterday, the FDA authorized the first pill in the U.S. to treat the effects of COVID-19 from home. According to reported studies, the Pfizer-made anti-viral pills are 89% effective at preventing serious illness or hospitalization when […]
Now that those who are 18 and over can receive the booster shot, Pfizer is requesting ages 16 to 17 to be able to receive the same option. Yesterday, Pfizer CEO and Chairman Albert Bourla tweeted out their announcement of a request to the U.S. Food and Drug Administration to expand the emergency use authorization […]
The Food and Drug Administration has issued a recall on the at-home Covid 19 test by Ellume Health. The Ellume at-home Covid test is an antigen test and uses a swap to take the sample from the nose. The FDA says the test kit has a high false-positive test result rate that is not acceptable. […]
As of yesterday, the U.S. Food and Drug Administration (FDA) announced that they will need more time to decide whether or not they will approve Moderna’s COVID-19 vaccine for use in children ages 12 to 17. The FDA informed Moderna on Friday of a rare side effect from the vaccine known as myocarditis, or the […]
Federal health regulators (FDA) have recently spoken out on how the kid-size doses of Pfizer’s COVID-19 vaccine appear highly effective at preventing symptomatic infections in elementary school children. The kid-sized dose also shows no unexpected safety issues. According to the FDA’s analysis, scientists concluded that in almost every scenario the vaccine’s benefit for preventing hospitalizations […]
After about 6 months into his presidency, President Joe Biden is in a standoff with senators within his own party about who should head the FDA. Right now, there is no sign of the spot being filled permantly anytime soon. CNN reported: “Dr. Janet Woodcock, a career official since 1986, has been serving as acting […]