FDA asks Sarepta to stop shipping gene therapy
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Rich Ice Cream Co. recalled numerous lots of its products on June 27 over potential contamination with Listeria monocytogenes.
The U.S. Food and Drug Administration has authorized the sale of Juul Labs' e-cigarette device and refill cartridges in tobacco and menthol flavors, after years of struggle with heightened regulatory scrutiny,
JUUL GETS ITS CROWN — The FDA authorized Juul’s applications on Thursday to sell e-cigarettes in the U.S., determining they’re “appropriate for the protection of public health” because their benefits to adult smokers of combustible cigarettes outweigh the risks to nonsmoking youths.
The 52 food standards pertain to canned fruits and vegetables, dairy products, baked goods, macaroni products, and other foods. The FDA has reviewed its portfolio of more than 250 food Standards of Identity to "make sure they are useful, relevant, and serve consumers in the best possible way."
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Supporters believe that FDA approval will make the drug more accessible. Right now, traditional psilocybin therapy offered at healing centers in the state is not covered by insurance.
The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market, providing relief to a company that has struggled for years after being widely blamed for sparking the teen vaping trend.
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Medpage Today on MSNCRLs Are the Low-Hanging Fruit of FDA Transparency, Experts SayFor instance, "the backlog of FOIAs ... is enormous," he said. Califf said the FDA has far greater opportunities for improved transparency -- especially in the stages of the drug approval process that happen long before CRLs are issued.
The regulator authorized the company to keep its e-cigarettes on the U.S. market after a federal ban in 2022 had pushed it to the brink of bankruptcy.
The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's antipsychotic drug in combination with Viatris' antidepressant Zoloft for treating adults with PTSD.