Tag Archives: Stephen Hahn

Via press release from the FDA: Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects …

ABC News reports: In an interview with Fox News Saturday, Trump, after seeming to take credit for the speed of the vaccine’s development, said that the Food and Drug Administration could have authorized the shot for emergency use “last week.” “They could have even done it a week sooner,” the president continued. “We do not feel that this could have …

The Washington Post reports: White House Chief of Staff Mark Meadows on Friday told Stephen Hahn, the commissioner of the FDA, to submit his resignation if the agency does not clear the nation’s first coronavirus vaccine by day’s end, according to people familiar with the situation who spoke on the condition of anonymity. The threat came on the same day …

Axios reports: White House Chief of Staff Mark Meadows has summoned FDA commissioner Stephen Hahn to the West Wing for a 9:30am meeting Tuesday to explain why he hasn’t moved faster to approve the Pfizer coronavirus vaccine, two senior administration officials told Axios. The meeting is shaping up to be tense, with Hahn using what the White House will likely …

The Washington Post reports: President Trump is lashing out at the Food and Drug Administration following a disclosure Monday that an experimental coronavirus vaccine from pharmaceutical giant Pfizer is more than 90 percent effective, convinced the timing — six days after Election Day — proves the “medical deep state” deliberately tried to sabotage his electoral prospects by delaying the results. …

This should totally firm up confidence in the COVID vaccine: Infuriated by the FDA’s defiance in a showdown over the Trump administration’s standards for authorizing a coronavirus vaccine, health secretary Alex Azar has spent recent weeks openly plotting the ouster of FDA chief Stephen Hahn. Azar has vented to allies within the Health and Human Services Department about his unhappiness …

“Decisions to authorize and approve any such vaccine or therapeutic will be made by the dedicated career staff at FDA through our thorough review processes and science will guide our decisions. “FDA will not permit any pressure from anyone to change that. I will fight for science, Mr. Chairman. I will fight for the integrity of the agency, and I …

The New York Post reports: The head of the US Food and Drug Administration is willing to fast-track a coronavirus vaccine as quickly as possible – even before Phase Three clinical trials end — as long as officials are convinced the benefits outweigh the risks, according to a report. Commissioner Stephen Hahn told the Financial Times that the move would …

Politico reports: FDA Commissioner Stephen Hahn [photo] is ousting his top spokesperson after only two weeks on the job, in a move that follows unhappiness with the agency’s communications strategy, according to an email he sent to senior leaders on Friday that was shared with POLITICO. “Effectively immediately, Emily Miller will no longer serve the FDA as the assistant commissioner …

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 …

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 …