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At issue is the FDA's regulatory power to approve drugs and continually evaluate their safety — a system that until now has been widely viewed as the gold standard for both safety and innovation
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The Food and Drug Administration is working with Ecuadorian authorities to investigate Negasmart, who has been supplying cinnamon to the three recalled applesauce brands.
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The Food and Drug Administration has approved the first vaccine for expectant mothers to shield their babies from RSV.
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The Supreme Court has left the case in the hands of the 5th U.S. Circuit Court of Appeals, which has scheduled oral arguments in the case for May 17.
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Anti-abortion advocates are trying to revive the long-dormant 1873 Comstock Act, which banned mailing of anything related to abortion or contraception, in a lawsuit about mifepristone, an abortion-inducing drug.
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If the case succeeds, it could have sweeping repercussions — for abortion providers and patients across the nation, as well as for the FDA's drug-approval process.
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The case, filed in Amarillo, challenges the Food and Drug Administration’s approval of mifepristone.
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Recent FDA changes now make hearing aids available over the counter to people 18 and over without a medical exam or a prescription. KERA’s Sam Baker talks about the need for this, and concerns about it, with Dr. William Even, an audiologist and clinical assistant professor in the otolaryngology department at UT Southwestern Medical Center.
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The person was immunocompromised, and officials said Tuesday they are trying to determine what role the virus played in the death. This is Texas' first death of someone with monkeypox.
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A new report looks at how and why the Food and Drug Administration plans to push pharmaceutical companies to loosen the restrictions. Lead author Dr. David Gerber of UT Southwestern Medical Center and Simmons Cancer Center has long been an advocate for change. He spoke with KERA’s Sam Baker.
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The Biden administration may scrap plans to expand eligibility for second boosters to younger adults. Instead, it's trying to speed up the next generation of boosters targeting the omicron variant.
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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.