FDA recently issued an emergency use authorization (EUA) for Abbott’s COVID-19 antigen test, the BinaxNOW COVID-19 Ag Card Home Test, for use by patients with a prescription.
The test is...
FDA recently authorized the first at-home influenza and COVID-19 diagnostic test intended for patients who are suspected of respiratory viral infection consistent with the coronavirus.
The test,...
Roche recently announced that its COVID-19 antibody test, Elecsys, received FDA emergency use authorization.
Elecsys Anti-SARS-CoV-2 S measures the level of antibodies to the spike protein of...
HHS and the Department of Defense (DoD) recently awarded an $11.6 million contract to Puritan Medical Products Company, LLC to boost domestic production of nasal swabs used for COVID-19 tests.
The...
President Trump recently issued two regulations to lower prescription drug pricing through a slew of new initiatives at aim prescription drug spending in Medicare.
The reforms are the direct...
FDA recently issued final guidance to encourage clinical trial diversity from the design to execution of the tests.
The guidance, Enhancing the Diversity of Clinical Trial...
FDA recently authorized the first COVID-19 serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection.
The emergency use authorization went to biotechnology...
HHS and the Department of Defense (DoD) jointly announced a $12.7 million contract to increase domestic production for two rapid point-of-care COVID-19 tests.
The contract is with InBios...
The Department of Justice (DOJ) recently announced an $8.3 billion settlement in which opioid manufacturer, Purdue Pharmaceuticals, agreed to plead guilty to a three-count felony.
As part of the...
A Pioneer Institute report found that market reforms using “push” and “pull” funding will help to combat the global antimicrobial resistance crisis.
The CDC considers...
HHS recently announced that American hospitals can go back to purchasing Gilead’s COVID-19 antiviral, Veklury (remdesivir), directly from the drug’s distributor starting.
Over the...
HHS and The Rockefeller Foundation recently signed an agreement to identify and share effective approaches for increasing rapid point-of-care (POC) COVID-19 testing in various communities.
Under...
The Department of Justice recently announced that Gilead agreed to pay $97 million to resolve healthcare fraud allegations that it violated the False Claims Act and illegally paid kickbacks to a...
The FDA recently finalized a rule that would allow prescription drug importation from Canada in FDA-authorized programs.
The final rule, part of the White House’s Safe Importation Action Plan,...
Bristol Myers Squibb and bluebird bio, Inc. recently announced that FDA accepted their request for a priority review for Idecabtagene vicleucel, a chimeric antigen receptor (CAR) T-cell therapy for the...
FDA recently proposed updates to its regulations to clarify the types of evidence the agency considers when determining the “intended use” of FDA-regulated products.
The proposed...
HHS and the Department of Defense (DoD) released two documents Wednesday outlining the Trump Administration’s COVID-19 vaccine distribution strategy.
The documents provide four necessary tasks...
Last week, HHS issued guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand access to safe and effective COVID-19 vaccines when they become available.
The...
Premier recently released four recommendations on how the US can implement a successful COVID-19 vaccination program once a vaccine becomes available to the public.
Currently, various...
FDA recently issued an emergency use authorization to Abbott for the first COVID-19 antigen test where results can be read directly from the testing card.
The BinaxNOW Ag Card is fast and...
