Legally Qualified: Can Employers Require Vaccines?
Can Employers Require COVID-19 Vaccinations?
The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more
The US Food and Drug Administration has finalized the framework for transitioning medical devices previously granted emergency use authorization or subject to particular enforcement policies to obtaining permanent marketing...more
For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products....more
The Novavax COVID-19 vaccine recently received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for individuals 18 and older, making Novavax the fourth COVID-19 vaccine to receive either...more
Last month, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 20 to 2 to advance S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (the “PREVENT Pandemics...more
On February 22, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar on two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization...more
The Food and Drug Administration (FDA) has recently undertaken a number of notable actions with respect to vaccines in response to the ongoing COVID-19 pandemic....more
In two draft companion guidance documents, the US Food and Drug Administration (FDA) establishes a proposed framework for transitioning medical devices currently marketed under emergency use authorization (EUA) or enforcement...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: Woodcock...more
Upcoming Hearings/Markups - October 26 - House Education and Labor Committee, Subcommittee on Workforce Protections and the Subcommittee on Civil Rights and Human Services Hearing: “Protecting Lives and Livelihoods:...more
A new submission for a Food and Drug Administration (FDA) emergency use authorization (EUA), new guidance for travelers entering the U.S. and continued studies into the efficacy of booster shots headlined this week’s...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: FDA issues...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: FDA...more
The COVID-19 vaccine approval process reached a major milestone, but the fourth U.S. wave of the COVID-19 virus has prompted some sobering projections about the future of the pandemic. COVID-19 Vaccine Receives Full FDA...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: FDA revokes...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA revokes...more
In Washington: The Centers for Disease Control and Prevention (CDC) said it is looking to let cruise lines resume trips in the U.S. by mid-July and changing some of the rules to allow the ships to sail. A spokeswoman for...more
A year into the current public health emergency, the FDA’s Center for Devices and Radiological Health (CDRH) announced on Thursday, April 15, 2021, that the center is “prioritizing and triaging our work using existing...more
China recently amended its primary regulation governing medical devices, the Regulation on Supervision and Administration of Medical Devices (2021 RSAMD), which will replace its previous 2014 version and become effective on...more
On March 3, 2021, FDA issued a statement acknowledging that certain entities produce certificates of registration for medical device manufacturers and clarifying that the agency does not issue such certificates. The agency...more
At the beginning of this week the FDA unveiled four new and updated guidance targeting vaccines, drugs and biologics, monoclonal antibodies and diagnostic tests. to address the impact of COVID-19 variants on the efficacy and...more
The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The SARS-CoV-2 virus has mutated over time,...more
FDA announced that as of last week, 327 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 243 molecular tests and sample collection devices, 70 antibody...more
Encouraging signs continue in the COVID-19 response, as the federal government looks to fine-tune the vaccine distribution process and additional vaccine options seem poised to enter the market....more
In Washington: The White House is reportedly considering mailing masks directly to Americans. The plans have been discussed but no formal proposal has been delivered to Biden, a White House official told NBC News. Discussions...more