FDA Spokesperson - ARCHIVED

Assistant Commissioner for Media Affairs, U.S. Food and Drug Administration. - ARCHIVED ACCOUNT

[FDA Spokesperson - ARCHIVED @FDASpox_Archive]

Important news form FDA today -> The first test authorized for #COVID19 that gets results in minutes directly from a card.
This test is authorized for certain point-of-care settings, like a doctor’s office or emergency room to begin.

[U.S. FDA @US_FDA]

FDA issued an emergency use authorization (EUA) for the first antigen #COVID19 test where results can be read directly from the testing card, a similar design to some pregnancy tests. https://t.co/e6DZtvxst7

[FDA Spokesperson - ARCHIVED @FDASpox_Archive]

Thread from Commissioner @SteveFDA on #COVIDー19 vaccine progress ...

[Dr. Stephen M. Hahn @SteveFDA]

FDA scientific reviewers who have long experience with vaccine development are encouraged by the rapid rate of enrollment in the ongoing clinical trials for a #COVID19 vaccine.

[FDA Spokesperson - ARCHIVED @FDASpox_Archive]

On decision-making, @SteveFDA said, " I would not participate in any decision that was made on anything other than the science."

[FDA Spokesperson - ARCHIVED @FDASpox_Archive]

.@SteveFDA: "I was trying to do what I do with patients, because patients often understand things in absolute terms vs relative terms. And I should've been more careful, there's no question about it. ... I frankly did not do a good job of explaining that." https://t.co/ug9qcTpo9y

[FDA Spokesperson - ARCHIVED @FDASpox_Archive]

.@SteveFDA: @POTUS wants us to be focused on urgency. "I have great faith in the 17,000 FDA employees who are terrific scientists, doctors, and nurses that we’re going to do that and move it forward for the American people. That's our promise to them.”

[FDA Spokesperson - ARCHIVED @FDASpox_Archive]

“FDA completely supports clinical trial performance because at the end of the day, clinical trials—particularly randomized clinical trials—provide gold standard information.” -- @SteveFDA

[FDA Spokesperson - ARCHIVED @FDASpox_Archive]

“There's a great demand for this. Doctors are ordering this for patients around the country. As Americans recover from #COVID19, it would be absolutely great for them to consider donating plasma to meet that demand.” -- @SteveFDA

[CBS Mornings @CBSMornings]

"I personally could have done a better job and should have done a better job at that press conference explaining what the data show regarding convalescent plasma. I can assure the American people that this decision was made based upon sound science and data." — @SteveFDA

[U.S. FDA @US_FDA]

Commissioner @SteveFDA on @CBSThisMorning today: "The Mayo Clinic convalescent plasma program has shown that there are promising efficacy data as well as safety associated with plasma."

Professionals & scientists at FDA independently made this decision with his support, he said.

[FDA Spokesperson - ARCHIVED @FDASpox_Archive]

Tune in 8am ET Tuesday morning for @SteveFDA on @CBSThisMorning to talk about the benefits of convalescent plasma treatment for COVID patients in hospital and more.

[FDA Spokesperson - ARCHIVED @FDASpox_Archive]

Thread from Dr. Hahn tonight... please read.

[Dr. Stephen M. Hahn @SteveFDA]

Media coverage of FDA’s decision to issue emergency authorization for convalescent plasma has questioned whether this was a politically motivated decision. The decision was made by FDA career scientists based on data submitted a few weeks ago.

[FDA Spokesperson - ARCHIVED @FDASpox_Archive]

@SteveFDA @Unrollme

[Media Affairs @FDAMedia]

PRESS RELEASE: FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising #COVID19 Treatment, Another Achievement in Administration’s Fight Against Pandemic https://t.co/mpN76gtrHN

[FDA Spokesperson - ARCHIVED @FDASpox_Archive]

@nielslesniewski Hi! Started a week ago.

[FDA Spokesperson - ARCHIVED @FDASpox_Archive]

To clarify, the @MayoClinic data compared those given convalescent plasma with a high level of antibodies from COVID to those given plasma with low levels.

So 35% more patients survived by getting the higher antibodies convalescent plasma.

[FDA Spokesperson - ARCHIVED @FDASpox_Archive]

Convalescent plasma has shown to be beneficial for 35% of patients. This risk reduction figure - shown in chart below - is from @MayoClinic data from expanded access program that was analyzed by FDAA for the emergency use authorization announced today.

[FDA Spokesperson - ARCHIVED @FDASpox_Archive]

Commission Hahn, as a doctor himself, responds on whether the success rates so far on using convalescent plasma on #COVID-19 patients is significant. Watch video below:

[U.S. FDA @US_FDA]

"A 35 percent improvement in survival is a pretty substantial clinical benefit," FDA Commissioner @SteveFDA said in relation to the convalescent plasma emergency use authorization issued today.

[U.S. FDA @US_FDA]

“In the independent judgment of experts and expert scientists at FDA ... #COVID19 convalescent plasma is safe and shows promising efficacy thereby meeting the criteria for an emergency use authorization.” -- FDA Commissioner @SteveFDA

[FDA Spokesperson - ARCHIVED @FDASpox_Archive]

@RookieCityCop @MarshallCohen To echo @SteveFDA comments, the 35 out of 100 patients who lived due to convalescent plasma treatment, that’s a breakthrough. #convalescentplasma #COVID

[FDA Spokesperson - ARCHIVED @FDASpox_Archive]

Today, the FDA finalized emergency use approval for convalescent plasma to treat #COVIDー19 patients. The data shows it had helped thousands of patients survive and go home to their families. More in link below... #convalescentplasma

[Media Affairs @FDAMedia]

PRESS RELEASE: FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising #COVID19 Treatment, Another Achievement in Administration’s Fight Against Pandemic https://t.co/mpN76gtrHN