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Emergency Response

February 16, 2021 | Daily News

Top FDA device center officials over the weekend acknowledged early agency missteps in regulating COVID-19 serology tests and said moving forward the government should not let serology tests enter the market unless they are authorized by FDA.

February 10, 2021 | Daily News

The White House named 12 people to its COVID-19 Health Equity Task Force on Wednesday (Feb. 10).

February 10, 2021 | Daily News

The Centers for Disease Prevention and Control announced Wednesday (Feb. 10) that double-masking or wearing a single, well-fitted mask is more effective at protecting against COVID-19 than a single disposable mask based on emerging science.

February 09, 2021 | Daily News

FDA on Tuesday night (Feb. 9) granted emergency use authorization for a combination of monoclonal antibodies from Eli Lilly, bamlanivimab and etesevimab, to treat patients who experience mild to moderate COVID-19 symptoms and are at risk of severe adverse health effects or hospitalization.

February 09, 2021 | Daily News

The Biden White House has yet to decide whether to restore FDA’s regulation of laboratory-developed tests as it faces pressure from current and former FDA officials to revoke a controversial move by the Trump HHS to ax FDA’s oversight of the products.

February 05, 2021 | Daily News

The federal government has directed six different manufactures to ramp up domestic production of non-prescription, at-home COVID-19 tests under the Defense Production Act, the White House’s COVID-19 Response Team revealed Friday (Feb. 5).

February 05, 2021 | Daily News

The federal government will use the Defense Production Act to build U.S.-based factories that will produce more than a billion surgical gloves every month, the White House COVID-19 Response Team told reporters Friday (Feb. 5).

February 05, 2021 | Daily News

Acting FDA Commissioner Janet Woodcock said COVID-19 vaccine makers testing vaccines against new variants and developing booster shots likely will need to provide the agency with new safety and immunity data, but more limited data might be permitted depending on how quickly new strains emerge and how effective current vaccines remain against them.

February 04, 2021 | Daily News

Former FDA and HHS officials told lawmakers during a Wednesday (Feb. 3) hearing that the United States needs to invest in reforming key components of the U.S. health care system to better respond to COVID-19 by, among other things, implementing a national COVID-19 testing strategy that establishes standards for testing and contact tracing and provides Americans with digital access to their test information, and using emerging technology to better coordinate vaccination records between states and jurisdictions.

February 02, 2021 | Daily News

The Biden administration announced that it will begin delivering COVID-19 vaccines directly to pharmacies in addition to the vaccines that have been allotted to states, territories and tribes to further the United States’ vaccination efforts as part of President Joe Biden’s national COVID-19 response strategy.

February 01, 2021 | Daily News

HHS and the Department of Defense have awarded a $230 million contract to Ellume to help the company scale up manufacturing of its FDA-authorized over-the-counter at-home COVID-19 test kits, which are currently priced at $30 each.

February 01, 2021 | Daily News

FDA is considering updating its COVID-19 emergency use authorization test templates to ask antigen test developers how they plan to monitor for variant strains of the virus and to ensure that authorized tests can properly diagnose the new strains.

January 27, 2021 | Daily News

The U.S. government will collaborate with monoclonal antibody developers to target the potentially serious impacts a new strain of COVID-19 found in South Africa poses to the therapy’s efficacy, the White House COVID-19 Response Team announced Wednesday (Jan. 27).

January 26, 2021 | Daily News

Nurses want FDA to completely end the reuse of N95 masks and say the agency’s latest action falls short, after FDA on Friday (Jan. 22) reissued an emergency use authorization that said the respirators should only be decontaminated and reused a maximum of four times.

January 26, 2021 | Daily News

FDA is keeping a close eye on existing and possible emerging COVID-19 mutations and is considering developing a pathway for potential changes to emergency authorized products, including vaccines, for COVID-19 should they be needed, acting agency chief Janet Woodcock said Monday evening (Jan. 25).

January 25, 2021 | Daily News

Moderna announced Monday (Jan. 25) it will begin trials for booster shots that, when paired with the company’s FDA-authorized COVID-19 vaccine, could offer increased protection against variant strains of the virus that have emerged out of the United Kingdom and South Africa, coming as U.S. health officials and experts from the World Health Organization say they’re keeping a close eye on the mutations.

January 22, 2021 | Daily News

President Joe Biden signed an executive order Thursday (Jan. 21) to set up a national public health job corps aimed at COVID-19 testing, contact tracing and vaccine outreach.

January 21, 2021 | Daily News

In its new COVID-19 national strategy released Thursday (Jan. 21), the Biden administration commits to a transparent, science-based, equitable COVID-19 response and outlines specific actions it will take to help rebuild trust between Americans and the federal government, which has severely diminished in the past year.

January 21, 2021 | Daily News

President Joe Biden unveiled a national COVID-19 testing strategy that aims to dramatically increase the number of Americans tested as part of a new seven-pronged massive public health effort to mitigate the spread of COVID-19.

January 20, 2021 | Daily News

President Joe Biden has tapped National Institute of Allergy and Infectious Diseases Director Anthony Fauci to head the U.S. delegation to the World Health Organization, as the new administration re-engages with WHO and reverses the Trump administration’s withdrawal from the organization.