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Emergency Response

January 14, 2021 | Daily News

President-elect Joe Biden late Thursday (Jan. 14) unveiled a $1.9 trillion COVID-19 relief package that would pump $20 billion into a national vaccination program that results in 100 million vaccinations by the end of his first 100 days.

January 11, 2021 | Daily News

FDA is working to identify new mutant strains of COVID-19 and analyze how they respond to current diagnostic tests, agency chief Stephen Hahn told reporters on a Friday (Jan. 8) press briefing, just a few hours before FDA alerted health care providers it has identified three emergency authorized tests that could produce false negative results with a potential mutated variant of SARS-CoV-2.

January 11, 2021 | Daily News

FDA Chief Stephen Hahn told reporters on Friday (Jan. 8) that the agency is working with the White House and industry to figure out how to increase availability of and speed up administration of COVID-19 vaccines, including by testing whether vaccines are effective at lower doses and considering novel clinical trial designs that would assess different vaccine dosing and administration methods.

January 07, 2021 | Daily News

HHS Assistant Secretary Brett Giroir said the department is “very confident” an improved congressional COVID-19 testing system will be in place in time for President-Elect Joe Biden’s inauguration, coming after FDA warned earlier this week that the test currently used by members of Congress could be faulty.

January 07, 2021 | Daily News

A pharmaceutical prescribing expert tells Inside Health Policy that FDA ignored its own data when it warned earlier this week that allowing patients to go longer than the authorized three to four weeks between COVID-19 vaccine inoculations is not supported by current scientific evidence.

January 05, 2021 | Daily News

Industry lawyers say it is unclear how FDA will handle on-site facility inspections as the COVID-19 health emergency spills into 2021 and sponsors of COVID-19 vaccines and therapeutics that received emergency use authorization move toward full approvals.

January 04, 2021 | Daily News

FDA announced late Monday evening (Jan. 4) that changing the doses for authorized COVID-19 vaccines is not backed by scientific evidence and could pose health risks despite recent suggestions by a top Operation Warp Speed official that some of the vaccines could be safely administered in half-doses.

December 16, 2020 | Daily News

Health policy experts, including former FDA Commissioner Scott Gottlieb, are blasting Operation Warp Speed officials’ decision to hold back distribution of nearly 3 million doses of Pfizer’s COVID-19 vaccine until it’s time to ship out second doses next month, saying that more lives could be saved by sending out additional initial doses now and getting more people vaccinated with the first dose upfront.

December 15, 2020 | Daily News

FDA on Tuesday (Dec. 15) authorized for emergency use the first fully at-home over-the-counter COVID-19 diagnostic test.

December 14, 2020 | Daily News

Liability protections have become enough of a sticking point for the bipartisan coalition of senators who proposed a $908 billion COVID-19 relief package that they’ve broken it into two bills -- tying in a separate, narrow bill the $160 billion for state, local and tribal governments to whether lawmakers can agree on liability protections.

December 12, 2020 |

The U.S. government plans to complete delivery of the initial doses of Pfizer and BioNTech’s COVID-19 vaccine to states by Wednesday (Dec. 16), Operation Warp Speed officials said Saturday (Dec. 12), less than 24 hours after FDA granted emergency use authorization for the vaccine to be administered to people ages 16 and up.

December 12, 2020 | Daily News

The U.S. government plans to complete delivery of the initial doses of Pfizer and BioNTech’s COVID-19 vaccine to states by Wednesday (Dec. 16), Operation Warp Speed officials said Saturday (Dec. 12), less than 24 hours after FDA granted emergency use authorization for the vaccine to be administered to people ages 16 and up.

December 09, 2020 | Daily News

LabCorp’s Pixel COVID-19 Test Home Collection Kit became the first direct-to-consumer non-prescription COVID-19 diagnostic test to receive emergency use authorization from FDA, the agency announced Wednesday evening (Dec. 9).

December 08, 2020 | Daily News

A pharmaceutical economics professor says the federal government should consider creating an agency, separate from FDA, of which the sole purpose would be to track drug use, create multiple drug shortage lists and develop shortage mitigation strategies.

December 04, 2020 | Daily News

An HHS spokesperson told Inside Health Policy that the department may outsource scientific reviews of emergency use authorization requests for COVID-19 laboratory-developed tests to other government agencies or outside contractors if FDA doesn’t conduct the reviews.

December 03, 2020 | Daily News

FDA will limit its feedback on emergency use authorization requests for COVID-19 diagnostic tests to just one round of questions in order to quickly move through submissions and make decisions on the applications, the agency told COVID-19 test developers on Wednesday (Dec. 2).

December 03, 2020 | Daily News

A top FDA device center official said on Wednesday (Dec. 2) that the agency hopes to soon publish an emergency use authorization template for prescription at-home COVID-19 serology tests that detect antibodies to SARS-CoV-2.

November 23, 2020 | Daily News

On Tuesday (Nov. 24), HHS will begin allocating the first 30,000 doses of Regeneron’s investigational monoclonal antibodies, casirivimab and imdevimab, which over the weekend received emergency use authorization from FDA for use in non-hospitalized patients with mild to moderate COVID-19.

November 18, 2020 | Daily News

FDA issued its first emergency use authorization for a rapid COVID-19 diagnostic that can be performed entirely at home late Tuesday (Nov. 18) night and hopes to approve similar tests in the upcoming weeks.

November 16, 2020 | Daily News

HHS has directed FDA to review emergency use authorization applications voluntarily submitted for COVID-19 laboratory-developed tests -- reviews that FDA told labs in October it would no longer conduct following HHS’ controversial August pronouncement that FDA lacked jurisdiction over LDTs.

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