News & Analysis as of

Vaccinations Federal Food Drug and Cosmetic Act (FFDCA)

Alston & Bird

Health Care Week in Review: HHS Finalizes 340B ADR Rule; House and Senate Hold Hearings on President’s FY 2025 HHS Budget

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: FDA Released Its User Fee Amendments For FY 2023

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Morrison & Foerster LLP - Class Dismissed

Pleading And Preemption: Immunization Against Vaccine Products Liability Claims

In a recent win for vaccine manufacturers, a district court found that federal law preempted claims against Merck, arising out of alleged injuries from the Gardasil vaccine. Herlth v. Merck & Co., Inc., No. 3:21-cv-438 (JAM),...more

Alston & Bird

Alston & Bird Health Care Week in Review - February 2022 #1

Alston & Bird on

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

Mintz - Health Care Viewpoints

Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started

It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12...more

Perkins Coie

COVID-19 Vaccine Questions Answered - Update

Perkins Coie on

With the surge of COVID-19 cases due to the Delta variant, many employers are considering whether to require employees to be vaccinated, how to encourage employee vaccinations, and the implications of vaccine policies for...more

Laner Muchin, Ltd.

COVID-19 Update: Changes in Face Covering Guidance and Considerations for Employers on Implementing a Vaccination Mandate

Laner Muchin, Ltd. on

As we enter our seventeenth month of the COVID-19 pandemic, fears that the pandemic is once again getting out of control continue to rise. With COVID-19 cases increasing across the country, due in part to the contagiousness...more

Proskauer - Law and the Workplace

DOJ Memo: The Food, Drug, and Cosmetic Act Does Not Prohibit Entities from Requiring Vaccines Subject to an EUA

In a memo dated July 6, 2021, the DOJ’s Office of Legal Counsel concluded that the COVID-19 vaccines’ status as products authorized for emergency use does not prohibit public and private entities from requiring them as a...more

Lathrop GPM

New Covid-19 Vaccination and Mask Guidance has Employers Rethinking Safety Protocols

Lathrop GPM on

Yesterday, on July 27, 2021, the U.S. Center for Disease Control (CDC) issued new COVID-19 guidance, including recommending face masks even for vaccinated people when they are in indoor public settings in geographic areas...more

Perkins Coie

DOJ Takes Stance on Mandatory COVID-19 Vaccine Policies: They Do Not Violate Federal Food and Drug Laws

Perkins Coie on

According to a legal opinion posted online on July 26, 2021, the U.S. Department of Justice officially took the position that the Food, Drug, and Cosmetic Act (FDCA)—which authorizes an “emergency use authorization” (EUA) for...more

Snell & Wilmer

Department of Justice Affirms Employers’ Ability to Mandate Vaccines

Snell & Wilmer on

When the EEOC confirmed months ago that employers could mandate Covid-19 vaccines without violating employment laws, the agency did not answer a lingering question regarding a non-employment statute, section 564 of the Food,...more

Jackson Lewis P.C.

To Mandate Or Not To Mandate: Department Of Justice Weighs In On Vaccination Mandates

Jackson Lewis P.C. on

Can employers mandate vaccines? The Department of Justice’s Office of Legal Counsel (OLC) says they can, but before employers do, they should consider the many legal and practical risks. On July 26, 2021, the OLC issued an...more

Pillsbury Winthrop Shaw Pittman LLP

FDA Regulatory Approvals as the U.S. Emerges from the Immediate COVID-19 Emergency

Emergency Use Authorizations will play a role as the pandemic eases, but a transition to ordinary course approvals is underway. As long as the COVID-related emergency is deemed to exist, fast-tracked FDA regulatory...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Mandating COVID-19 Vaccines in Hospitals

On June 4, 2021, a federal judge denied a request for a temporary restraining order that would have blocked Houston Methodist Hospital (the “Hospital”) from requiring its employees to receive one of the currently-available...more

Parker Poe Adams & Bernstein LLP

Public and Private Employees File First Challenges to Mandatory Vaccination Policies

In a pair of notable new lawsuits, employees of both public and private employers have filed legal challenges to mandatory COVID-19 vaccination policies. First, on April 16, 2021, in the Middle District of North Carolina, a...more

Ruder Ware

Emergency Use Authorization Vaccines – A Caution to Employers

Ruder Ware on

Happy New Year! As we move into 2021, we know that many of you are considering whether to require employees to get the COVID-19 vaccination. The current COVID-19 vaccines have received Emergency Use Authorization (“EUA”)...more

Womble Bond Dickinson

For Emergency Use Only?

Womble Bond Dickinson on

While requiring vaccinations for school attendance and in some occupations is common, the issue of employers requiring vaccination for COVID-19 is currently a hot topic. There is currently no Food and Drug Administration...more

Polsinelli

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

Polsinelli on

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

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