Tag: Food and Drug Administration

New Strawberry-Flavored H.I.V. Drugs for Babies Are Offered at $1 a Day

About 80,000 babies and toddlers die of AIDS each year, mostly in Africa, in part because their medicines come in hard pills or bitter syrups that are very difficult for small children to swallow or keep down. But on Friday, the Indian generic drug manufacturer Cipla announced a new, more palatable pediatric formulation. The new […]

Read More

C.D.C. Reports More E. Coli Illnesses Linked to Romaine Lettuce

The Centers for Disease Control and Prevention said Tuesday that it had identified 27 more people who were ill from the recent outbreak of E. coli infection linked to romaine lettuce from Salinas, Calif., bringing the total number of reported cases to 67. The C.D.C. reported no fatalities but said the outbreak affected 19 states, […]

Read More

Juul Says Its Focus Was Smokers, but It Targeted Young Nonsmokers

SAN FRANCISCO — In the face of mounting investigations, subpoenas and lawsuits, Juul Labs has insisted that it never marketed or knowingly sold its trendy e-cigarettes and flavored nicotine pods to teenagers. As youth vaping soared and “juuling” became a high school craze, the company’s top executives have stood firm in their assertion that Juul’s […]

Read More

Trump Warns a Flavor Ban Would Spawn Counterfeit Vaping Products

WASHINGTON — Two months after announcing that he planned to ban the sale of most flavored e-cigarettes, President Trump on Friday once again raised concerns about such restrictions during a lively, televised White House meeting that brought together top executives from the health community and the tobacco and vaping industries. “If you don’t give it […]

Read More

Trump’s F.D.A. Nominee Sidesteps Questions About Banning Flavored Vaping Products

President Trump’s nominee for Food and Drug Administration commissioner, Dr. Stephen M. Hahn, declined to answer questions from senators in both parties about whether he would push for a ban on flavored vaping products at a confirmation hearing Wednesday. The questions placed Dr. Hahn, a cancer executive without any Washington or governing experience, at the […]

Read More

The Cowardice Behind Trump’s Vaping-Ban Retreat

Is there any limit to the Trump administration’s willingness to endanger public health and safety for political purposes? First, it weakened environmental protection standards, despite clear evidence that the air we breathe is irreparably harming us and our children. Then it formally left the Paris Agreement on climate change, despite its being the only available […]

Read More

To Drive Down Insulin Prices, W.H.O. Will Certify Generic Versions

With insulin prices skyrocketing and substantial shortages developing in poorer countries, the World Health Organization said on Wednesday that it would begin testing and approving generic versions of the drug. Agency officials said they hoped to drive down insulin prices by encouraging makers of generic drugs to enter the market, increasing competition. At the moment, […]

Read More

Banning E-Cigarettes Could Do More Harm Than Good

The nation is facing two distinct vaping-related health crises: surging e-cigarette use among teenagers and a lung-injury outbreak that has sickened more than 2,000 people and killed at least 40. Both have exposed yawning gaps in the nation’s public health apparatus. But instead of closing those gaps, policymakers have turned to a much more straightforward […]

Read More

Are There Benefits to Collagen Supplements?

It will make your skin look dewy and fresh, your bones and nails strong, and your joints pain-free. These are the claims made by the countless manufacturers of collagen supplements that come in the form of powders, pills and creams. For that reason, it’s no surprise that collagen has become a widely sought-after ingredient in […]

Read More

Juul Ends E-Cigarette Sales of Mint-Flavored Pods

Juul Labs, the nation’s largest seller of e-cigarettes, said on Thursday that it would stop selling mint-flavored pods, which have become especially popular among teenagers. The move precedes an anticipated federal flavor ban that is to be announced soon, one that the Food and Drug Administration initially had said would include mint as well as […]

Read More

Stephen Hahn, a Noted Cancer Researcher, to Be Nominated to Head the F.D.A.

President Trump was expected on Friday to nominate Dr. Stephen M. Hahn, a top executive at The University of Texas M.D. Anderson Cancer Center, to be the next commissioner of the Food and Drug Administration, according to a source familiar with the president’s decision. Mr. Trump’s selection of Dr. Hahn will fill the vacancy left […]

Read More

Did a Drug Company Illegally Experiment on a Louisiana Prisoner?

In May, a drug company called BioCorRx began offering free Naltrexone implants, a slow-release drug that reduces opioid cravings, to incarcerated people. The first prisoner underwent the surgical procedure at the Louisiana State Penitentiary, a former cotton plantation. Although Naltrexone in the form of daily oral pills or monthly injections is FDA-approved, the longer-lasting implants […]

Read More

How Contaminated Stool Stored in a Freezer Left a Fecal Transplant Patient Dead

In a frank and public act of self-examination, a group of doctors at Massachusetts General Hospital published an article Wednesday in the New England Journal of Medicine detailing the missteps that led to the death of a cancer patient who received a fecal transplant as part of an experimental trial. The man who died, and […]

Read More

U.S. Blames Drug Shortages on Low Prices and a ‘Broken Marketplace’

Chronic drug shortages that threaten patient care are caused by rock-bottom prices for older generic medicines and a health care marketplace that doesn’t run on the rules of supply and demand, among other factors, according to a federal report published on Tuesday. The report, the work of a task force led by the Food and […]

Read More

Johnson & Johnson Says Recalled Baby Powder Doesn’t Have Asbestos

Johnson & Johnson said on Tuesday that it did not find asbestos in multiple tests of a bottle of baby powder that the Food and Drug Administration said contained trace amounts of the carcinogen. The company had recalled 33,000 bottles of the product earlier this month after the regulator said it discovered evidence of chrysotile […]

Read More

Generic Version of Xanax Is Recalled by F.D.A.

ImageAlprazolam, a generic version of Xanax, is prescribed to manage anxiety and panic disorders.Credit…Science History Images, via Alamy The Food and Drug Administration has announced a nationwide recall of a batch of alprazolam, a generic version of Xanax, because of potential contamination. The manufacturer, Mylan Pharmaceuticals, said Friday that the voluntary recall was because of […]

Read More

Women Should Be Warned of Breast Implant Hazards, F.D.A. Says

Women considering surgery to receive breast implants should be warned in advance of the risk of serious complications, including fatigue, joint pain and the possibility of a rare type of cancer, the Food and Drug Administration said on Wednesday. Agency officials are urging manufacturers to print a boxed warning on the packaging of the implants, […]

Read More

That New Alzheimer’s Drug? Don’t Get Your Hopes Up Yet

Biogen, the drug company, said on Tuesday that it would ask the Food and Drug Administration to approve an experimental drug, aducanumab, to treat people with mild cognitive impairment and the earliest signs of Alzheimer’s disease. About 10 million Americans might qualify for treatment if the drug were approved, according to Michel Vounatsos, the company’s […]

Read More

Johnson & Johnson Recalls Asbestos-Tainted Baby Powder

Johnson & Johnson is recalling a shipment of baby powder after the Food and Drug Administration discovered evidence of asbestos, the company said on Friday, after months spent denying the presence of the carcinogen in its talc-based products. In a test, the regulator found trace levels of chrysotile asbestos in samples from a bottle of […]

Read More

Juul Suspends Online Sales of Flavored E-Cigarettes

Juul Labs announced Thursday that it would temporarily halt online sales of flavored e-cigarettes like mango, products the company had already stopped distributing to retail stores as public outrage mounted over the soaring rate of teenage vaping. Facing multiple federal and state investigations into its marketing practices, Juul said it decided to discontinue the sales […]

Read More

Faced With a Drug Shortfall, Doctors Scramble to Treat Children With Cancer

A critical drug that serves as the backbone of treatment for most childhood cancers, including leukemias, lymphomas and brain tumors, has become increasingly scarce, and doctors are warning that they may soon be forced to consider rationing doses. Persistent shortages of certain drugs and medical supplies have plagued the United States for years, but physicians […]

Read More

He Tried E-Cigarettes to Quit Smoking. Doctors Say Vaping Led to His Death.

OMAHA — In the spring, Kathleen Fimple buried her husband, John, and by the fall, she had reluctantly settled into her new life as a widow. She accepted what the doctors told her: that he had died at 68 from respiratory failure and pulmonary disease after years of smoking cigarettes, coupled with a bout of […]

Read More