Tag: Food and Drug Administration

F.D.A. Issues New Images to Add to Warnings on Cigarette Packages

WASHINGTON — The corpse is gone. So are the grief-stricken woman and the man struggling to smoke despite a hole in his windpipe. Nine years after the Food and Drug Administration first proposed graphic images as new warnings on cigarette packs but was thwarted by major tobacco companies in a successful court battle, the agency […]

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Dozens of Young People Hospitalized for Breathing and Lung Problems After Vaping

Nearly three dozen young people have been hospitalized around the country in recent weeks for severe respiratory problems after vaping either nicotine or marijuana, stumping doctors treating them. The Illinois, Minnesota and Wisconsin public health departments are investigating these cases and at least 20 additional emergency admissions that doctors suspect are related to vaping some […]

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Scientists Discover a Cure for the Deadliest Strain of Tuberculosis

TSAKANE, South Africa — When Tsholofelo Msimango joined a clinical trial of new tuberculosis drugs, she was 20 years old and weighed just 57 pounds. Stricken with a deadly strain of tuberculosis, Ms. Msimango was terrified. She was to be transferred to Sizwe Tropical Diseases Hospital in Johannesburg. The nurses in the township here told […]

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Drinking Bleach Won’t Cure Cancer or Anything Else, F.D.A. Says

The Food and Drug Administration was dragged into the online world of medical misinformation this week, telling consumers not to drink bleach solutions that are being marketed as cures for autism, cancer, H.I.V./AIDS and other medical conditions. It was the latest example of how health authorities must sometimes pit science against the viral power of […]

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This Drug Will Save Children’s Lives. It Costs $2 Million.

Spinal muscular atrophy is a condition often fatal by age 2. Babies with the disorder have a rare genetic mutation that prevents the nervous system from controlling certain muscles. As they grow to be toddlers, these children struggle to move their limbs, to swallow food, to talk. The Food and Drug Administration recently approved a […]

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Ads for CBD as Cure-All Are Everywhere, but Regulation Is Scant

Scientists at Virginia Commonwealth University in Richmond, Va., were concerned when a young man contacted their department last year complaining of a heart-pounding, hallucinogenic high he had neither expected nor wanted to have. The team, led by the forensic toxicologist Michelle R. Peace, had published a study about mysterious ingredients in vaping liquids. That’s how […]

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Novartis C.E.O. Defends Company’s Decision to Withhold False Data From the F.D.A.

The chief executive of Novartis on Wednesday defended the company’s decision to delay telling the Food and Drug Administration about manipulated data involving its $2.1 million gene therapy treatment, saying that it “thoroughly, aggressively” investigated the issue and that patient safety was never threatened. Vas Narasimhan, the chief executive, also indicated in a call with […]

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Novartis Hid Manipulated Data While Seeking Approval for $2.1 Million Treatment

The drug maker Novartis concealed manipulated data from the Food and Drug Administration while applying for approval of an extremely expensive gene therapy treatment and then delayed reporting the issue, the agency said on Tuesday. Officials said the inaccurate data, which involved testing in mice of two different strengths of the treatment, did not affect […]

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These Medical Devices Are Inserted Into 500,000 Patients Each Year — but Are Tough to Sterilize

In hospitals around the world, the snakelike duodenoscope is regarded as an indispensable tool for diagnosing and treating diseases of the pancreas and bile ducts. But these fiber-optic devices have a remarkable drawback: Although they are inserted into the upper part of the small intestine through the mouth and constantly reused, they cannot be sterilized […]

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Abortion Pills Should Be Everywhere

One afternoon about a year ago, just as the Senate began considering Brett Kavanaugh’s nomination to the Supreme Court, I logged on to Day Night Healthcare, an online pharmacy based in India, and ordered a pack of abortion pills. A few hours later, I got a call from a Day Night customer-service agent with a […]

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Sesame Allergy More Common Than Once Thought, Study Finds

At least one million children and adults in the United States are allergic to sesame, an ingredient used in everything from hummus to snack bars, researchers reported on Friday. The finding indicates that sesame allergy is more prevalent than previously known, although still far less common than peanut allergy. But sesame is not among the […]

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Juul Says It Doesn’t Target Kids. But Its E-Cigarettes Pull Them In.

Over 3.6 million middle and high school students used e-cigarettes last year, up by 1.5 million over 2017. The use of Juul, the most popular brand in the country, appears to have led this alarming increase among middle and high school students. This should not be a surprise. The founders of Juul Labs say that […]

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Trump Administration Proposes Allowing Drug Imports for Cheaper Prescriptions

The Trump administration said on Wednesday that it was taking steps to make it easier for less expensive prescription drugs to be imported from other countries, particularly Canada, a move that has long been supported by progressives but has encountered fierce opposition from the pharmaceutical industry. Under the plan, the administration said it would propose […]

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Breast Implants Linked to Rare Cancer Are Recalled Worldwide

Textured breast implants made by Allergan, linked to an unusual cancer, are being recalled in the United States at the request of the Food and Drug Administration, the agency announced on Wednesday. Worldwide, 573 cases and 33 deaths from the cancer have been reported, with 481 of the cases clearly attributed to Allergan implants, the […]

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Is Your Heartbeat Off, or Blood Sugar High? On the Road, You Can Keep Track

A new batch of apps and pocket-size medical devices that work with a smartphone or smartwatch are changing travel for people with serious medical conditions. The devices allow people with heart conditions, diabetes and epilepsy to discreetly check up on themselves in airport terminals, in train or bus stations, in hotels or even as they […]

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Sound, Fury and Prescription Drugs

Nothing typifies the failures of health care in the United States like prescription drugs. Americans pay more for their medications — including those developed in America, with taxpayer dollars — than residents of any other country in the world. So many patients are rationing or outright skipping essential medications that stories of people dying for […]

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Elizabeth Warren Calls on Former F.D.A. Chief to Quit Pfizer Board

Senator Elizabeth Warren on Tuesday called on Dr. Scott Gottlieb, the former commissioner of the Food and Drug Administration, to resign from the board of Pfizer, saying his decision to join one of the country’s leading pharmaceutical companies “smacks of corruption.” Ms. Warren, who is seeking the Democratic presidential nomination, said in a public letter […]

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F.D.A. Links 16 Brands of Dog Food to Canine Heart Disease

The Food and Drug Administration identified 16 brands of dog food that had been linked to heart disease in dogs that eat them, according to a report the agency published on Thursday. In the report, the F.D.A. named for the first time the pet food brands most frequently associated with adverse events. In descending order […]

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