Tag Archives: FDA

FDA To Consider First-Ever OTC Birth Control Pill

Axios reports: Pharmaceutical company HRA Pharma submitted an application to the Food and Drug Administration on Monday asking to sell a birth control bill over-the-counter, rather than via prescription. If approved, it would be the first ever birth control pill to be available over-the-counter in the U.S. The application was submitted just weeks after the Supreme Court overturned Roe v. …

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FDA: Booster Against New Subvariants Coming This Fall

Via press release from the FDA: As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19. Following a thorough discussion on June 28, 2022, an overwhelming majority of the advisory committee voted in favor …

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Federal Court Temporarily Blocks FDA Ban On Juul Sales

The New York Times reports: A federal appeals court on Friday granted a temporary reprieve to Juul Labs that will allow it to keep its e-cigarettes on the market, pending further court review of a decision just a day earlier by the Food and Drug Administration to ban sales of the company’s products. It will be up to the appeals …

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FDA Orders Juul Brand To Stop Selling E-Cigarettes

The New York Times reports: The Food and Drug Administration on Thursday ordered Juul to stop selling e-cigarettes on the U.S. market, a profoundly damaging blow to a once-popular company whose brand was blamed for the teenage vaping crisis. The order affects all of Juul’s products on the U.S. market, the overwhelming source of the company’s sales. Juul’s sleek vaping …

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Carlson: The Feds Want To Lower Nicotine In Cigarettes To Make Working Class Men “Passive, Easy To Control”

Media Matters has the transcript: Yesterday the FDA announced it’s planning to remove virtually all nicotine from cigarettes. Now nicotine is not the thing that gives you cancer. Nicotine is the thing — it’s addictive but it also increases mental acuity but they’re taking that out. According to the Wall Street Journal, the agency will also ban Juul e-cigarettes. Now …

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FDA Approves COVID Vaccines For Youngest Children

NBC News reports: The Food and Drug Administration on Friday authorized both Pfizer-BioNTech and Moderna’s Covid-19 vaccines for young children, though the CDC still needs to sign off before shots can be administered. The Pfizer vaccine was authorized for children ages 6 months to 4 years, while the Moderna vaccine was authorized for children ages 6 months to 5 years, …

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FDA Advisors Recommend Fourth COVID Vaccine

The Washington Post reports: A panel of independent vaccine experts recommended Tuesday that the Food and Drug Administration authorize a coronavirus vaccine developed by the Maryland biotechnology company Novavax, paving the way for the fourth shot in the United States. The experts’ vote was 21 in favor of authorizing the Novavax vaccine, with one abstention. But it remained unclear when …

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Organic Strawberries Blamed For Hepatitis A Outbreak

The Washington Post reports: A multistate outbreak of hepatitis A infections in the United States and Canada is likely to have been sparked by contaminated organic strawberries sold in leading grocery stores, the Food and Drug Administration warned, urging customers to throw out any uneaten batches that may have been frozen for later consumption. “Consumers, restaurants, and retailers should not …

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Abbott Reaches Deal To Reopen Baby Formula Plant

CNBC reports: Abbott has reached an agreement with the Food and Drug Administration to reopen its manufacturing plant in Michigan to help ease a nationwide shortage of baby formula, the company announced Monday. Abbott said it can restart the Michigan plant within two weeks subject to FDA approval. However, it would take six to eight weeks from the start of …

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Feds Issue Plan To Ban Sales Of Menthol Cigarettes

The Associated Press reports: The U.S. government on Thursday released its long-awaited plan to ban menthol cigarettes and flavored cigars, citing the toll on Black smokers and young people. “The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit,” said HHS Secretary Xavier Becerra, in a statement. He added that the …

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FDA Approves First Ever COVID-19 Breathalyzer Test

Via press release from the CDC: Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile …

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FDA Approves Second Booster For People Over Age 50

USA Today reports: People age 50 and up are now eligible for a second booster dose of COVID-19 vaccine at least four months after their first, the Food and Drug Administration said Tuesday. “Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk …

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FDA Approves First Condoms Specifically For Anal Sex

Via press release from the FDA: Today, the U.S. Food and Drug Administration authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse. The condoms, which will be marketed as the One Male Condom, are also indicated as a contraceptive to help reduce the risk of pregnancy and the …

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Family Dollar Closes 400 Stores After Rat Feces Notice

The Washington Post reports: A rodent infestation at a Family Dollar warehouse has prompted the discount store chain to recall a wide range of products sold at hundreds of stores throughout the southern United States. Health concerns about the rat infestation at an Arkansas distribution center have also led to the temporary closure of more than 400 stores in six …

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FDA May Approve Second Vax Booster In The Fall

Yahoo News reports: U.S. health regulators are looking at authorizing a potential fourth dose of a COVID-19 vaccine in the fall, the Wall Street Journal reported on Sunday citing sources familiar with the matter. The Food and Drug Administration has been reviewing data to authorize a second booster dose of the messenger RNA vaccines from Pfizer Inc and partner BioNTech …

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FDA: Family Dollar Products Might Contain Rat Feces

Via press release from the FDA: Today, the U.S. Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. 1, 2021, through the present from Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee may be unsafe for consumers to use. The impacted products originated from the company’s distribution facility in …

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Pfizer Postpones FDA Request On Vax For Kids Under 5

NBC News reports: Pfizer-BioNTech is postponing its rolling application to the Food and Drug Administration to expand the use of its two-dose Covid-19 vaccine for children ages 6 months to 4 years. The move means that vaccines for this age group will not be available in the coming weeks, a setback for parents eager to vaccinate their young children. Pfizer …

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Vax For Kids Under 5 May Be Approved This Month

The Washington Post reports: Coronavirus vaccines for children younger than 5 could be available far sooner than expected — perhaps by the end of February — under a plan that would lead to the potential authorization of a two-shot regimen in the coming weeks, people briefed on the situation said Monday. The FDA urged the companies to submit the application …

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FDA Grants Full Final Approval To Moderna Vaccine

The Washington Post reports: The Food and Drug Administration has granted full approval to Moderna’s coronavirus vaccine, the agency announced Monday. Moderna’s vaccine, now known as Spikevax, was previously available under emergency use authorization and is the second coronavirus vaccine to get full FDA approval. Pfizer and BioNTech’s product was approved in August. Moderna, a biotechnology company, said Monday that …

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FDA May Curb Use Of Treatment Pushed By DeSantis

CNN reports: The FDA could decide in the coming days to take steps to curb the use of antibody treatments produced by Eli Lilly and Regeneron, the source said, pointing to the growing body of evidence that shows their monoclonal therapies don’t effectively neutralize the virus’ Omicron variant. The NIH had recently updated its guidelines to advise clinics against using …

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