The decision by an advisory committee may lead to Food and Drug Administration approval of the first treatment for humans that uses the CRISPR gene-editing system.
Category: Food and Drug Administration
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Fruit Purée Pouches May Contain Lead, F.D.A. Warns Parents
Children who have had WanaBana apple cinnamon fruit purée pouches should get a blood test, federal officials said. An investigation found that the purée had “extremely high concentrations of lead.”
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F.D.A. Experts Will Vote on a Cure for Sickle Cell Disease
The treatment from the company Vertex would be the first medicine to use the gene editing tool CRISPR.
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Hearing Aids Are More Affordable, and Perhaps More Needed, Than Ever
Over-the-counter devices have been available for a year now. New research suggests they may have unexpected benefits.
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Doctors Wrestle With A.I. in Patient Care, Citing Lax Rules
The F.D.A. has approved many new programs that use artificial intelligence, but doctors are skeptical that the tools really improve care or are backed by solid research.
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Eyedrops From Major Brands May Cause Infection, F.D.A. Says
Target, CVS and Rite Aid are pulling products from shelves after federal investigators found unsanitary conditions and recommended a recall.
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Salmonella Outbreak Linked to Packaged Onions Sickens 73
Gills Onions recalled packages of diced onions after the company was notified of an investigation. Public health officials said 15 people were treated at hospitals.
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Family Dollar Recalls Hundreds of Products Sold in 23 States
The products, which include over-the-counter drugs, medical devices and hygiene supplies, were not stored at proper temperatures, the company said.
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California’s Ban on Red Food Dye Puts FDA on the Spot
The dye was banned in cosmetics after a study suggested it might be a carcinogen. Yet federal regulations still permit its use in foods, stoking concerns that helped build support for the new state law.
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FDA Moves to Ban Sale of Vuse Menthol Vapes
R.J. Reynolds menthol e-cigarettes are top sellers with an estimated $1.6 billion in annual sales. The company vowed to fight the ruling in court.
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FDA Issues Warning Over Misuse of Ketamine Therapy
Unsupervised treatment — fueled by telemedicine prescriptions — for various psychiatric problems poses a number of health risks, the agency said.
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Illicit Vapes and E-Cigarettes Flood Stores as F.D.A. Struggles to Combat Imports
Some vapes are appearing with increasing nicotine levels that approach those in a carton of cigarettes. U.S. regulators did not authorize them, but have failed to keep them off shelves.