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Emergency Use Authorization (EUA) Biden Administration

Goodwin

The Long (Un)Winding Road, Part 2: The FDA’s Final Transition Guidances for COVID-19 Devices

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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

Foley Hoag LLP

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

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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

Alston & Bird

Medical Products Supply Chain Week in Review – October 2021 #2

Alston & Bird on

Last week, the FDA authorized the booster doses for both the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines and mix and match booster doses. The FDA also proposed a new rule for over-the-counter (OTC) hearing aids. The...more

McGuireWoods Consulting

Washington Healthcare Update - September 2021 #3

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

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

Alston & Bird

Medical Products Supply Chain Week in Review – September 2021 #1

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Over the last two weeks, the President signed Executive Orders requiring all federal employees and contractors to be vaccinated. The White House COVID-19 Response Team announced a $3 billion investment in the vaccine supply...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

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – June 2021 #5

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Last week, the FDA added new heart health risk information to mRNA vaccines’ fact sheets. In addition, the U.S. seized unauthorized COVID-19 drugs en route from Bangladesh and India to Mexico. ...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – June 2021 #3

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Last week, President Biden announced a new COVID-19 vaccine commitment to the world. In addition, Novavax’s COVID-19 vaccine candidate met the primary endpoint in its Phase 3 trial. Please see details for these and other...more

MoFo Life Sciences

COVID-19 Vaccines: And Then There Were Three (Again)

MoFo Life Sciences on

On December 11, 2020, a SARS-CoV-2 (COVID-19) vaccine developed by Pfizer and BioNTech became the first to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Since then, two others...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: White House Unveils New Vaccine Allocation Strategy

The Biden administration unveiled a new vaccine allocation strategy designed to address vaccine hesitancy and access issues. This new strategy coincides with a number of studies on COVID-19 variants that underscore the need...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, May 2021 # 2

Hogan Lovells on

In Washington: The Biden administration announced Wednesday that it supports a proposal to waive international patent protections for COVID-19 vaccines.  U.S. Trade Representative Katherine Tai said in a statement that the...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, May 2021

Hogan Lovells on

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

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review - May 2021 #1

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In the past week, the U.S. government announced new vaccination milestones reached and encouraged more people to get vaccinated. Please see details for these and other supply chain developments below: On April 27, President...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: Guidance and Developments as Global Vaccination Continues

This week, the CDC announced updated guidance regarding outdoor gatherings, and the Department of Labor is advancing new workplace safety standards. Meanwhile, dwindling U.S. vaccination rates and global vaccine access are...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, April 2021 # 9

Hogan Lovells on

In Washington: The Biden administration will ban most travel from India starting Tuesday amid a surge in coronavirus cases in the country. "On the advice of the Centers for Disease Control and Prevention, the Administration...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review - April 2021 #4

Alston & Bird on

In the past week, President Biden announced that the U.S. had reached a new vaccination milestone. Also, the FDA and CDC decided to resume the use of Johnson & Johnson’s vaccine, and the FDA finished its inspection of the...more

Snell & Wilmer

Governor Ducey Signs Executive Order 2021-09 Banning Use of Vaccine Passports in Arizona

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On Monday April 19, 2021, Arizona Governor Doug Ducey signed Executive Order 2021-09 banning vaccine passports in Arizona—also known as digital health passports (“DHPs”). The Executive Order (“EO”) prevents local governments,...more

Jackson Lewis P.C.

COVID-19 Vaccination: Setting Up On-Site Programs

Jackson Lewis P.C. on

The Biden administration has called for all people at least 18 to be eligible for the COVID-19 vaccine by April 19, 2021. Most states have already done so. A BenefitsPro article cites a 2017 survey from the Society for...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – April 2021 #1

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In the past week, President Biden revealed his American Jobs Plan, with important implications for domestic medical product manufacturing. The President also announced a new vaccination progress target, while the week marked...more

Saul Ewing LLP

Staying Vigilant: New Developments Highlight Unknowns About Vaccinations and Evolving Workplace Safety Rules

Saul Ewing LLP on

In President Biden’s March 11, 2021 speech, he urged everyone to “stay vigilant” against the virus even as more vaccines are rolled out. The same applies to employers. Three recent developments—an employee lawsuit challenging...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review - March 2021 #1

Alston & Bird on

In the past week, President Biden signed the Executive Order on America’s Supply Chains, kicking off a comprehensive review of supply chain risks. Meanwhile, the FDA issued an emergency use authorization (EUA) for the Janssen...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, February 2021 #17

Hogan Lovells on

In Washington: Senate Democrats made their final pitch on Wednesday to Senate Parliamentarian Elizabeth MacDonough to include a minimum wage hike in coronavirus relief legislation. The Parliamentarian decides whether...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, February 2021 # 11

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In Washington: President Biden will join leaders of the Group of Seven (G-7) nations this Friday for a virtual summit focused on the global response to COVID-19, the White House said Sunday. Other discussions at the summit...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – February 2021 #3

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In the past week, the Biden Administration further increased COVID-19 vaccine supply and signed contracts with Pfizer and Moderna for 200 million more doses, putting the Administration on track to have enough supply for 300...more

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