Tag Archives: FDA

The Washington Post reports: The Food and Drug Administration has withdrawn its emergency use authorization for hydroxychloroquine to treat coronavirus patients. President Trump had repeatedly promoted the antimalarial drug as a way to prevent or treat covid-19. The agency said Monday in a statement that “it is no longer reasonable to believe” the drug may be effective against covid-19 or …

Axios reports: An at-home coronavirus collection kit made by health care startup Everlywell has received emergency authorization from the Food and Drug Administration, the agency announced Saturday. This is the only kit that can be used with multiple coronavirus tests, although two other at-home swabs have received authorization from the FDA. The swabs collected at home will be sent to …

The Associated Press reports: The head of the Food and Drug Administration said Friday his agency has provided new guidance to the White House after data suggested that a rapid COVID-19 test used by President Donald Trump and others every day may provide inaccuracies and false negatives. Commissioner Steve Hahn said that if a person is suspected of having the …

Reuters reports: U.S. Food and Drug Administration Commissioner Stephen Hahn is in self-quarantine for a couple of weeks after coming into contact with someone who tested positive for COVID-19, an FDA spokesman told Reuters late on Friday. Hahn immediately took a diagnostic test and was tested negative himself for the novel coronavirus, FDA spokesman Michael Felberbaum said in an emailed …

The Hill reports: Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb said Sunday that the ouster of federal vaccine chief Richard Bright will “set us back” in combating the coronavirus pandemic. “I know Rick Bright well … he was effective. He was a vaccine expert, so I was sorry to see him go,” Gottlieb said on CBS’ “Face the …

Bloomberg News reports: The U.S. Food and Drug Administration warned patients against taking two malaria medications that have been talked up by President Donald Trump for Covid-19, unless carefully monitored in a hospital or as part of a clinical trial. The FDA said it was issuing the warning for the drugs, hydroxychloroquine and chloroquine, after reports that patients taking them, …

The New York Times reports: The Food and Drug Administration on Tuesday said it had granted emergency clearance to the first in-home test for the coronavirus, a nasal swab kit that will be sold by LabCorp. The agency said that LabCorp had submitted data showing the home test is as safe and accurate as a sample collection at a doctor’s …

ABC News reports: The United States is close to its peak of the novel coronavirus disease, Food and Drug Administration Commissioner Stephen Hahn said on ABC’s “This Week.” “The models do show that we are very close to the peak. So I think that information is accurate,” Hahn said. “This has been a really fast-moving outbreak, so we really have …

The Daily Beast reports: The Food and Drug Administration is demanding that conspiracy theorist Alex Jones stop advertising dubious dietary supplements as coronavirus treatments and threatening legal action if he doesn’t comply. The FDA sent a letter to Jones and his website InfoWars on Thursday demanding that he stop telling the viewers of his popular internet broadcasts that they can …

Roll Call reports: A top FDA official Thursday sought to assure a U.S. public still wondering if COVID-19 can be transmitted by food and feeling unsettled by grocery shelves empty of their favorite foods. Frank Yiannas, Food and Drug Administration deputy commissioner of food policy and response, acknowledged during a press call that the United States has entered a “new …

NBC News reports: Amid what it’s calling an “urgent need for blood,” the FDA revised its blood donor guidelines on Thursday, significantly easing the restrictions on men who have sex with men. The new guidelines reduce the donation deferral period for sexually active gay and bisexual men from 12 months to three, meaning these otherwise healthy men will now have …

The Washington Post reports: The Food and Drug Administration has given emergency approval to a Trump administration plan to distribute millions of doses of anti-malarial drugs to hospitals across the country, saying it is worth the risk of trying unproven treatments to slow the progression of the disease in seriously ill coronavirus patients. There have only been a few, very …

The Washington Post reports: The FDA late Friday approved the first coronavirus test that can be conducted entirely at the point of care for a patient — and deliver results in 45 minutes. The FDA granted “emergency use authorization” to Cepheid, a California company that makes a rapid molecular test for the coronavirus. Getting results in 45 minutes would be …

Bloomberg News reports: Roche Holding AG won emergency approval from the U.S. government for a highly automated coronavirus test, potentially speeding up tenfold the ability to test patients. The U.S. Food and Drug Administration granted an “emergency use authorization” to the test, which runs on Roche’s cobas 6800/8800 systems. The tool also is available in Europe and countries that accept …

CNBC reports: The Food and Drug Administration said Thursday it has issued a ban on flavored vaping products, with the exception of tobacco and menthol. Under the new rule, companies that do not stop the distribution of fruit and mint flavors within 30 days are at risk of regulatory action by the FDA, the agency said. “The United States has …

Bloomberg News reports: A possible ban on flavored e-cigarettes appears to be back on the table, as the White House is currently reviewing a new guidance from the FDA. The White House Office of Management and Budget (OMB) began reviewing the guidance from FDA on Dec. 26. The administration finished reviewing an earlier version of the guidance in November, but …

As of today, the new smoking age is in effect: The Food and Drug Administration (FDA) has officially raised the legal age to buy tobacco products in the United States from 18 to 21. The move applies to all tobacco products, e-cigarettes and vaping cartridges, and comes after President Trump last week signed a $1.4 trillion spending package that included …

The Washington Post reports: State and federal health officials investigating mysterious lung illnesses linked to vaping have found the same chemical in samples of marijuana products used by people sickened in different parts of the country and who used different brands of products in recent weeks. The chemical is an oil derived from vitamin E. Investigators at the U.S. Food …

Courthouse News reports: The Seventh Circuit reinstated pet owners’ class action fraud suit against Hill’s Pet Food, ruling that the FDA did not authorize the company’s “prescription” label on high-priced pet food found to be no different than regular pet food. Holly Vanzant and Dana Land sued Hill’s Pet Nutrition under the Consumer Fraud Act after allegedly discovering that Hill’s …

The New York Times reports: The corpse is gone. So are the grief-stricken woman, the rotting teeth 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 warnings on cigarette packs but was thwarted by tobacco companies in a successful court battle, the agency announced …