FDA, Sarepta and gene therapy
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Marty Makary says the FDA will plow ahead with big plans on ultra processed foods, dietary guidelines, and expedited drug and devices reviews.
The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.
Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid mounting concerns over their potential safety risks.
The recall of more than 160,000 bottles of levothyroxine sodium, which went into effect June 20, was upgraded to a Class II recall on July 23. Class II recalls occur when use of the drug poses a moderate public health risk, according to the FDA.
The recall has been given a Class II classification, indicating there is a significant level of risk posed to consumers in Minnesota.
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Commissioner Marty Makary said in an interview with Politico’s Dasha Burns that the FDA will “look at the data” surrounding the abortion drug, mifepristone, including concerns” that pregnant women are suffering coercion to take the pill “outside the prescribing authority of a physician.
Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.
The U.S. drug regulator said on Friday a unit of Johnson & Johnson issued a correction for certain lots of a part related to its surgical stapler and classified the action as "most serious".
FDA Recalls Single-Serve Coffee Pods Over Potentially Toxic Brewing Risk originally appeared on Men's Fitness. Keurig users, beware. A popular coffee brand has issued a voluntary recall of its single-serve coffee pods.
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The US Food and Drug Administration appears poised to continue with a plan to ban prescription fluoride supplements at a time when many experts say that access to the products has become especially important.