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Emergency Response

March 10, 2020 | Daily News

FDA postponed all of its foreign inspections, effective immediately, until April, FDA chief Stephen Hahn announced Tuesday (March 10) -- coming amid a wave of event and meeting cancellations throughout the United States as coronavirus spreads throughout the country, and as other countries mandate quarantines.

March 06, 2020 | Daily News

By next week, public health labs and hospitals should have enough COVID-19 diagnostic test kits to conduct up to 4 million tests, HHS Secretary Alex Azar told reporters Friday (March 6), shortly after President Donald Trump signed into law an emergency coronavirus supplemental funding bill that gives $61 million to FDA for medical product shortage response efforts and that waives certain Medicare telehealth restrictions during the COVID-19 public health emergency.

March 05, 2020 | Daily News

FDA will receive $61 million for COVID-19 response efforts under the fiscal 2020 supplemental funding deal that passed the Senate in a 96-1 vote Thursday (March 5).

March 04, 2020 | Daily News

FDA is working with four laboratories to deploy COVID-19 diagnostic tests that have not yet received emergency use authorization (EUA) but that have already been validated and certified by FDA to perform high-complexity testing.

March 03, 2020 | Daily News

Several antimicrobial resistance experts have begun to cite concerns about a possible waive of secondary bacterial and fungal infections in COVID-19 patients that could evolve into antimicrobial resistance diseases and said the lack of new antibiotic development could exacerbate an already-climbing death rate from the epidemic.

March 03, 2020 | Daily News

Several antimicrobial resistance experts have begun to cite concerns about a possible wave of secondary bacterial and fungal infections in COVID-19 patients that could evolve into antimicrobial-resistant diseases and said the lack of new antibiotic development could exacerbate an already-climbing death rate from the epidemic.

March 02, 2020 | Daily News

Over the weekend, FDA unveiled a new policy that allows certain laboratory-developed tests (LDTs) designed to detect COVID-19 to be used prior to gaining emergency use authorization (EUA) from the agency.

February 28, 2020 | Daily News

FDA announced the first shortage of a human drug as a result of the COVID-19 outbreak and used the opportunity to push legislative proposals it says would help the agency prevent or mitigate medical product shortages.

February 26, 2020 | Daily News

President Donald Trump appointed Vice President Mike Pence to lead the administration’s coronavirus response efforts during a White House press briefing on Wednesday (Feb. 26), and Pence said the White House will bring in additional personnel to support the efforts.

February 26, 2020 | Daily News

Democrats pounced on HHS Secretary Alex Azar after he refused Wednesday (Feb. 26) to promise that a coronavirus vaccine would be affordable for everyone.

February 26, 2020 | Daily News

Senate appropriators on Tuesday (Feb. 25) grilled HHS Secretary Alex Azar on whether the White House’s $2.5 billion supplemental funding request is enough to respond to the coronavirus outbreak and to beef up the U.S. supply of masks, ventilators and other personal protective equipment given other cuts sought by the White House.

February 26, 2020 | Daily News

Days before HHS requested $2.5 billion from Congress to develop drugs and equipment for the coronavirus response, a group of 46 House Democrats cautioned the administration against awarding companies exclusive licenses for coronavirus drugs invented with taxpayer money, and they said the administration “must use every tool of the federal government to ensure a coronavirus vaccine is affordable and accessible.”  

February 26, 2020 | Daily News

Democratic presidential candidates on Tuesday (Feb. 25) blasted the Trump administration for requesting fiscal 2021 funding cuts for the Centers for Disease Control and Prevention and the National Institutes of Health in the midst of the coronavirus outbreak.

February 07, 2020 | Daily News

FDA Commissioner Stephen Hahn on Friday (Feb. 7) told a group of reporters that the agency is currently not aware of any disruption to the medical supply chain in China that could be caused by the coronavirus outbreak.

February 04, 2020 | Daily News

FDA granted emergency use authorization to the first diagnostic test to detect novel coronavirus, the agency announced Tuesday (Feb. 4).

January 31, 2020 | Daily News

The medical device lobby is actively working with the Chinese and U.S. governments and stakeholders to ensure providers and patients have access to medical technologies that can help diagnose and prevent the spread of novel coronavirus, the group told Inside Health Policy on Thursday (Jan. 30), amid reports that China is experiencing shortages of masks, gowns and gloves.

January 28, 2020 | Daily News

FDA, the National Institutes of Health and the Office of the Assistant Secretary for Preparedness and Response are researching possibilities for vaccines, diagnostics and therapeutics to respond to the novel coronavirus, of which there are now five known cases in the United States, HHS Secretary Alex Azar said during a press briefing Tuesday (Jan. 28).

January 27, 2020 | Daily News

Diagnostic test makers who want to pursue emergency use authorization for tests to detect novel coronavirus should contact FDA, the agency said in a press release Monday (Jan. 27) as part of an update on the agency’s response efforts.

October 04, 2019 | Daily News

FDA warned the public, in a consumer alert Friday (Oct. 4), to stop using vaping products that contain tetrahydrocannabinol (THC). However, one cannabis industry group argued the response from FDA seems “overly broad” as no cannabis product has been definitively proven to be the cause of the vaping-related lung injury outbreak.

September 25, 2019 | Daily News

FDA on Tuesday (Sept. 24) announced the first FDA-approved vaccine for both monkeypox and smallpox, a disease that FDA biologics director Peter Marks said many Americans have no immunity to and that could pose a national security threat if it were released intentionally.

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