News & Analysis as of

Emergency Use Authorization (EUA) Centers for Disease Control and Prevention (CDC)

Mintz - Health Care Viewpoints

The End of the Federal COVID-19 Public Health Emergency is Near: What to Expect as HHS Transitions beyond the Emergency Phase

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

Weintraub Tobin

From Saving the World to Fighting Over IP: Moderna and Pfizer/BioNTech

Weintraub Tobin on

One of the most amazing accomplishments in the field of biotechnology has been the development and distribution of a vaccine against SARS-CoV-2 (COVID 19). The numbers tell the story. The time from when the coronavirus’...more

Foley & Lardner LLP

FDA Allows Pharmacists to Prescribe the COVID-19 Antiviral Paxlovid

Foley & Lardner LLP on

On July 6, the U.S. Food and Drug Administration (FDA) revised its emergency use authorization (EUA) for the COVID-19 antiviral treatment PaxlovidTM (nirmatrelvir and ritonavir) to allow prescribing by pharmacists for quicker...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: New Vaccine EUA Expected

Updates on vaccines for young children and a massive study on the efficacy of mask-wearing in schools headline this week’s COVID-19 news....more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: Pediatric COVID-19 Patients

A number of recent studies have sought to identify commonalities among COVID-19 patients under the age of 18 who have required hospitalization. In addition, many new studies have worked to measure the impact of the COVID-19...more

Foley Hoag LLP

Review of COVID-19 Testing Guidance for Travelers to the U.S.

Foley Hoag LLP on

As of December 6, 2021, all air passengers 2 years or older (regardless of vaccination or antibody status) with a flight departing to the United States from a foreign country are required to show a negative COVID-19 viral...more

Patrick Malone & Associates P.C. | DC Injury...

Kids now can get Covid shots. Will they? And what about the new anti-Covid pills?

Even as the coronavirus batters parts of the country, notably the Mountain West, public health officials are pointing to key ways in which Americans could safely and effectively further quell the pandemic that has claimed...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: Additional Booster Shots Recommended as FDA Prepares to Evaluate Vaccines for Younger Children

Booster Shot Endorsements - Last week, the U.S. Food and Drug Administration (FDA) advisory committee endorsed one of the mRNA COVID-19 vaccines and the single-dose vaccine to be used as a booster shot. This week, FDA...more

Tarter Krinsky & Drogin LLP

U.S. Travel Bans Lifted Effective November 8: What Foreign Visitors Need to Know

In a Twitter announcement on October 15, the White House announced that the U.S. will introduce a new travel policy that will begin on November 8, permitting foreign nationals access to the United States provided they have...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: FDA Considers COVID-19 Pill, Travel Restrictions To Be Lifted

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

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: A Pill To Treat COVID-19?

A promising new COVID-19 treatment grabbed headlines this week, along with new updates on one mRNA vaccine manufacturer’s path to potentially seeking Food and Drug Administration (FDA) approval on vaccines for children...more

Bricker Graydon LLP

Pfizer’s COVID booster doses now available for certain groups of people

Bricker Graydon LLP on

Following days of lengthy debates, 3rd doses of the Pfizer-BioNTech COVID-19 vaccine or “boosters” can now be officially administered to certain individuals in the U.S., as endorsed by the U.S. Food and Drug Administration...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: Domestic and International Vaccine News

Clinical trials and public health recommendations relating to booster vaccines and potential vaccines for children under the age of 12 continue to be front and center in the United States’ domestic COVID-19 response....more

Parker Poe Adams & Bernstein LLP

CDC Adds COVID-19 Vaccination Mandate for Green Card Applicants

The U.S. government recently imposed additional restrictions on foreign nationals related to the COVID-19 pandemic. Beginning October 1, 2021, foreign nationals applying for permanent residency (green cards) must provide...more

Alston & Bird

Alston & Bird Health Care Week in Review - September 2021 #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

Alston & Bird

Medical Products Supply Chain Week in Review – August 2021 #4

Alston & Bird on

Last week, Roche announced a shortage of its drug Actmera/RoActmera, which is used to treat COVID-19. The company, however, does have a mitigation strategy that it plans to implement to lessen the impact. The White House...more

Ward and Smith, P.A.

"Emergency Use" No More: FDA Approves First COVID-19 Vaccine

Ward and Smith, P.A. on

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

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: Booster Shots Continue To Gain Steam

Recent announcements on the prospect of booster shots for all vaccinated Americans, a vaccine mandate for staff at federally funded nursing homes and an encouraging uptick in vaccinations marked an eventful week in the...more

Alston & Bird

Medical Products Supply Chain Week in Review – August 2021 #3

Alston & Bird on

Last week, the FDA amended the Moderna and Pfizer-BioNTech emergency use authorizations (EUAs) to allow an additional dose of the mRNA COVID-19 vaccine for immunocompromised individuals. In addition, the Secretaries of...more

Bailey & Glasser, LLP

10 Considerations for Employers Contemplating Mandatory Vaccination Policies

Bailey & Glasser, LLP on

If you’re an employer contemplating implementing a mandatory COVID-19 vaccination policy for your workforce, you aren’t alone. With COVID-19 cases surging around the country and leading to new Centers for Disease Control and...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

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

Morrison & Foerster LLP

A Return To Normalcy? Check Your Local Rules – An Update On Mask Litigation And Guidelines

Nine months ago, we discussed several issues that had been raised by COVID-19 face mask-related litigation. Soon after, COVID-19 infection rates spiked to unprecedented levels. But with the emergency use authorization of...more

Maynard Nexsen

The FDA Revokes EUAs for Decontamination Systems and Non-NIOSH-Approved Respirators (i.e., KN95 Respirators)

Maynard Nexsen on

Since early last year, the United States Food and Drug Administration (FDA) issued several Emergency Use Authorizations (EUAs) for personal protective equipment (PPE) products to address concerns about their availability...more

Bricker Graydon LLP

Ohio bill prohibits COVID-19 vaccination mandates for public schools and universities; Outlaws mandates of vaccines without “full”...

Bricker Graydon LLP on

On June 28, 2021, the Ohio legislature passed House Bill (H.B.) 244. If approved by Governor DeWine, H.B. 244 would prohibit Ohio public schools and universities from requiring that students and employees receive the COVID-19...more

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