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
With less than two weeks left until the end of the federal COVID-19 Public Health Emergency (PHE), which is set to expire on May 11, 2023, the Department of Health and Human Services (HHS) is preparing to transition certain...more
In early 2023, the Biden administration announced and set into motion its plans to wind down a number of pandemic-related programs and allow the COVID-19 public health emergency (PHE) declaration, which has been in effect...more
The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as...more
The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance documents. The Transition...more
On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more
In the wake of the Department of Health and Human Services’ (HHS) February announcement that they will be discontinuing the COVID-19 public health emergency (PHE) declaration on May 11, 2023, the United States Food and Drug...more
The U.S. Food & Drug Administration (FDA) issued two new versions of guidance documents for COVID-19 tests on January 12, 2023: Policy for Coronavirus Disease-2019 Tests (the “COVID-19 Test Guidance”) and Policy for...more
On October 17, 2022, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released the list of guidance documents proposed for publication in fiscal year 2023. While it is unclear if...more
The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human...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
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
Upcoming Hearings/Markups - January 11 - Senate Health, Education and Labor Committee Hearing: “Addressing New Variants: A Federal Perspective on the COVID-19 Response” 10:00 a.m....more
During the ongoing COVID-19 pandemic, the Center for Devices and Radiological Health (CDRH) in the U.S. Food and Drug Administration (FDA or the Agency) issued a series of Emergency Use Authorizations (EUAs) and guidance...more
On November 15, 2021, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued the fifth edition of the Agency’s guidance entitled “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.”...more
As the COVID-19 pandemic progressed, the U.S. Food and Drug Administration (FDA) sought to provide timely guidance to the relevant stakeholders to support continuity and response efforts. Notwithstanding, on August 19, 2020,...more
On November 15, the U.S. Department of Health and Human Services (HHS) withdrew a controversial Trump-era HHS Policy Change that effectively prevented the Food and Drug Administration (FDA) from reviewing laboratory-developed...more
On November 15, 2021, the U.S. Department of Health and Human Services (HHS) announced the withdrawal of the policy established during the previous administration that limited U.S. Food and Drug Administration’s (FDA) ability...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
This week in Washington: Debt ceiling measure signed by President Biden; default averted for at least a month. Discussions about budget reconciliation continue....more
This week in Washington: Reconciliation delayed; short-term debt ceiling fix passed....more
Upcoming Hearings/Markups - September 27 - House Rules Committee Meeting: to discuss H.R. 3110 — PUMP for Nursing Mothers Act, H.R. 3992 — Protect Older Job Applicants (POJA) Act and H.R. 2119 — Family Violence Prevention...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
There was a time in which employers and employees weren’t vexed with viruses, vaccines, and their respective duties and rights. That seems like a long time ago, but it wasn’t. The World Health Organization declared the...more