Tag Archives: FDA

The New York Times reports: The Food and Drug Administration is preparing to authorize use of the Pfizer-BioNTech Covid-19 vaccine in adolescents 12 to 15 years old by early next week, according to federal officials familiar with the agency’s plans, opening up the nation’s vaccination campaign to millions more Americans. The news is highly anticipated: Eager parents have been counting …

NBC News reports: The Food and Drug Administration announced Thursday it will begin the process of banning menthol tobacco cigarettes, as well as all flavored cigars — a move heralded as one expected to improve the health of groups most likely to smoke menthol products, including children and Black Americans. “With these actions, the FDA will help significantly reduce youth …

NBC News reports: The Biden administration is expected to announce this week that it will propose a ban on menthol cigarettes, an action urgently sought by tobacco opponents and civil rights groups that say African Americans have been disproportionately hurt by the industry’s aggressive targeting of Black communities. The administration also is poised to say it will seek to ban …

ABC News reports: Women seeking an abortion pill will not be required to visit a doctor’s office or clinic during the COVID-19 pandemic, U.S. health officials said Tuesday in the latest reversal in an ongoing legal battle over the medication. The Food and Drug Administration announced the policy change a day earlier in a letter to the American College of …

The New York Times reports: The Food and Drug Administration on Saturday authorized Johnson & Johnson’s single-shot Covid-19 vaccine for emergency use, beginning the rollout of millions of doses of a third effective vaccine that could reach Americans by early next week. The announcement arrived at a critical moment, as the steep decline in coronavirus cases seems to have plateaued …

NBC News reports: An independent advisory panel to the Food and Drug Administration voted Friday to recommend that the agency authorize Johnson & Johnson’s Covid-19 vaccine. Members of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, voted unanimously in favor of recommending authorization. The FDA is not required to go along with the committee’s recommendation, but is widely …

Via press release from the FDA: Today, the U.S. Food and Drug Administration announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. This reflects an alternative to the preferred storage of the undiluted vials in …

Via press release from the FDA: We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19. These are all reasonable questions to consider and evaluate in clinical trials. However, at this …

Via press release from the FDA: On December 30, 2020, Midwestern Pet Food, Inc. announced a recall of certain lots of Sportmix pet food products after FDA was alerted about reports of at least 28 dogs that have died and eight that have fallen ill after consuming the recalled Sportmix pet food. Multiple product samples were tested by the Missouri …

CNBC reports: An influential Food and Drug Administration advisory panel on Thursday overwhelmingly backed Moderna’s coronavirus vaccine, a key step paving the way to distribute the second Covid-19 vaccine in the United States next week. An emergency use authorization means the FDA will allow some people to receive the vaccine as the agency continues to evaluate data. It isn’t the …

Via press release from the FDA: Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects …

The Wall Street Journal reports: The Food and Drug Administration said Tuesday that the Covid-19 vaccine developed by Moderna is “highly effective,” suggesting the vaccine could soon be added to the arsenal against the pandemic. Moderna’s documents posted by the FDA included new data suggesting that its vaccine begins to prevent asymptomatic infections after the first dose. The ability of …

ABC News reports: In an interview with Fox News Saturday, Trump, after seeming to take credit for the speed of the vaccine’s development, said that the Food and Drug Administration could have authorized the shot for emergency use “last week.” “They could have even done it a week sooner,” the president continued. “We do not feel that this could have …

CNBC reports: The Food and Drug Administration has approved Pfizer and BioNTech’s coronavirus vaccine for emergency use, a monumental turning point in the once-in-a-century pandemic that has taken nearly 300,000 American lives in less than a year and wreaked havoc on the U.S. economy. FDA Chief Scientist Denise Hinton told Pfizer in a letter Friday that she was authorizing the …

The Washington Post reports: White House Chief of Staff Mark Meadows on Friday told Stephen Hahn, the commissioner of the FDA, to submit his resignation if the agency does not clear the nation’s first coronavirus vaccine by day’s end, according to people familiar with the situation who spoke on the condition of anonymity. The threat came on the same day …

Forbes reports: Members of FDA’s Vaccine and Related Biological Products Advisory Committee endorsed Pfizer and BioNTech’s Covid-19 vaccine candidate on Thursday, clearing the last hurdle before emergency use authorization from the federal agency. The committee, also called VRBPAC, met for nine hours to discuss all aspects of the new Covid-19 vaccine, from risk and safety to how Pfizer and BioNTech …

Via press release from the FDA: AvKARE, Pulaski, TN is voluntarily recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the consumer level. These products have been recalled due to a product mix-up of the listed two separate products inadvertently packaged together during bottling at a 3rd party facility. Unintentional consumption of sildenafil …

The Hill reports: The U.S. Food and Drug Administration’s vaccines and related biological products advisory committee on Thursday morning is set to discuss Pfizer’s request for emergency use authorization of its COVID-19 vaccine. The hearing is scheduled to begin at 9AM Eastern. CNBC reports: The non-binding decision from the agency’s Vaccines and Related Biological Products Advisory Committee, an outside group …

CNN reports: 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 …

The New York Times reports: The coronavirus vaccine made by Pfizer and BioNTech provides strong protection against Covid-19 within about 10 days of the first dose, according to documents published on Tuesday by the Food and Drug Administration before a meeting of its vaccine advisory group. The finding is one of several significant new results featured in the briefing materials, …