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Emergency Response

March 17, 2020 | Daily News

In light of the growing coronavirus threat and reported hand sanitizer shortages, FDA announced Saturday (March 14) it will not pursue enforcement action against compounders, including pharmacists, federal facilities, or outsourcing facilities, producing hand sanitizers for consumers -- provided certain conditions are met -- until the declared national emergency has ended.

March 17, 2020 | Daily News

FDA late Monday evening (March 16) gave states authority to authorize coronavirus diagnostic tests in their own states and said private laboratories can develop and use coronavirus diagnostic tests prior to FDA approval.

March 16, 2020 | Daily News

The White House Coronavirus Task Force on Monday (March 16) gave more details on the new phase of COVID-19 testing announced Sunday, saying it will begin to track test results from private labs and offering a timeline for the rollout of the new diagnostic tests.

March 16, 2020 | Daily News

The National Institutes of Health announced the launch of the world's first COVID-19 vaccine trial on Monday (March 16).

March 12, 2020 | Daily News

Centers for Disease Control and Prevention Director Robert Redfield committed to waive coronavirus test fees for all Americans, including the uninsured, during a heated exchange with Rep. Katie Porter (D-CA) during a House Oversight & Reform Committee hearing Thursday (March 12).

March 11, 2020 | Daily News

As the spread of coronavirus places a spotlight on long-standing issues in the pharmaceutical supply chain and lawmakers seek solutions, the newest drug shortage bill, House Energy & Commerce Committee member Scott Peters’ (D-CA) Preventing Drug Shortages Act (H.R. 6080), brings together bipartisan ideas that a policy expert says would help address supply issues during the outbreak by increasing supply chain transparency and reporting.

March 11, 2020 | Daily News

House Energy & Commerce Committee leaders from both parties have requested FDA brief them by March 23 on the effect the coronavirus outbreak has had on the drug and device supply chain and on how the agency plans to combat potential shortages.

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.

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