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An NPR investigation found stalled confirmatory trials and lax enforcement are plaguing the FDA's accelerated approval of drugs for urgent medical needs.
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FDA Commissioner Robert Califf says a nongovernmental research group will convene experts to deliver the evaluations within 60 business days.
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Birth control pills are available in the U.S. only with a prescription. Now a drugmaker is asking the FDA to approve a progestin-only contraceptive that would be available without one at pharmacies.
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The U.S. federal agency said on Twitter that the stay temporarily suspends the marketing denial order while it conducts further review, but does not rescind it.
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The Food and Drug Administration will have to decide the exact recipe, but a combination shot is expected that adds protection against a version of the omicron variant to the original vaccine.
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The company "will finally be held accountable for creating the youth vaping epidemic," the advocacy group Parents Against Vaping e-cigarettes told NPR. Juul said it plans to fight the decision.
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As the Food and Drug Administration weighs approval of COVID-19 vaccinations for children under age 5, Florida Surgeon General Joseph Ladapo is opposed to the potential change.
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Advisers to the Food and Drug Administration overwhelmingly voted to recommend that it authorize Novavax's two-dose vaccine against COVID-19.
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COVID-19 vaccinations for children younger than 5 could start right after the Juneteenth holiday.
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The Centers for Disease Control and Prevention's advice opens a third COVID-19 shot to healthy elementary-age kids — just like what is already recommended for everybody 12 and older.
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The Food and Drug Administration expanded authorization of Pfizer-BioNTech's COVID vaccine to enable kids ages 5 to 11 who were vaccinated at least five months ago to get a third shot.
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Abbott, one of the largest formula makers in the U.S., has reached an agreement with the government to bring a closed factory back on line. And the FDA is easing some restrictions on imported formula.