News & Analysis as of

Food and Drug Administration (FDA) FDA Approval Coronavirus/COVID-19

Goodwin

FDA Approves Moderna’s and Pfizer/BioNTech’s Updated COVID-19 Vaccines

Goodwin on

On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more

Snell & Wilmer

Regulatory Matters – FDA Updates Emergency Use Authorization for Paxlovid

Snell & Wilmer on

A little over two years ago, the FDA authorized Paxlovid for emergency use for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Approves Sandoz Biosimilar for Tysabri®

It was not so long ago that many, including members of Congress, were bemoaning the slow approval and introduction into the marketplace of biosimilar alternatives to (generally expensive) biologic drugs.  See "Trump...more

Holland & Knight LLP

Holland & Knight Health Dose: October 18, 2022

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

Epstein Becker & Green

COVID-19 Vaccination and the Fetal Cell Line Conundrum for Employee Religious Objections

Epstein Becker & Green on

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

Parker Poe Adams & Bernstein LLP

New COVID-19 Vaccine May Provide Option for Religious Objectors

Last week, the Food and Drug Administration (FDA) authorized a fourth coronavirus vaccination, approving a new shot developed by Novavax. Unlike the Pfizer and Moderna products, this vaccine does not use messenger RNA...more

Epstein Becker & Green

FDA Greenlights Pharmacists to Prescribe COVID-19 Drug Paxlovid

Epstein Becker & Green on

Questions Remain for Pharmacy Test-to-Treat Programs Last week, the U.S. Food and Drug Administration (FDA) revised the Emergency Use Authorization (EUA) for Paxlovid to authorize state-licensed pharmacists to prescribe the...more

Snell & Wilmer

FDA Approves Second Booster

Snell & Wilmer on

Yesterday, the FDA authorized a second COVID-19 booster dose for Americans ages 50 and older, along with some immunocompromised individuals, at least four months after their initial booster....more

Knobbe Martens

FDA Approval for Novel Medical Devices Remains a High Priority, Despite COVID-19

Knobbe Martens on

In addition to its significant efforts to fast track the approval of COVID-19 related devices, the FDA’s Center for Devices and Radiological Health (CDRH) has also maintained its high priority focus on supporting innovation...more

Morgan Lewis

FDA Proposes Framework for Transitioning COVID-Related Medical Devices from EUA/Enforcement Discretion to Permanent Marketing...

Morgan Lewis on

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

Goodwin

Planning for the End: FDA Issues Draft Guidance for Transitioning EUA and Enforcement Policy Medical Devices Marketed During the...

Goodwin on

During the COVID-19 public health emergency, the United States Food and Drug Administration (FDA) has issued hundreds of Emergency Use Authorizations (EUAs) and numerous enforcement policies to facilitate the availability of...more

Holland & Knight LLP

FDA Outlines Post-Pandemic Plan for Medical Devices Now Marketed Under Special COVID Rules

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical devices that have been marketed under special...more

Alston & Bird

FDA Authorizes Two Oral COVID-19 Drugs – Medical Products Supply Chain Week in Review

Alston & Bird on

In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more

Robinson+Cole Health Law Diagnosis

HHS Again Requires FDA Premarket Review for COVID-19 Tests

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more

Husch Blackwell LLP

FDA’s Withdrawal of Temporary Guidance for Alcohol-Based Hand Sanitizers

Husch Blackwell LLP on

In March 2020, the Food and Drug Administration (FDA) issued temporary guidance documents allowing for the increased production of alcohol-based hand sanitizer during the COVID-19 outbreak. Due to that guidance, most...more

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

As Delta variant slams hospitals, forecast warns of 100,000 more virus deaths

The coronavirus keeps ripping through the country with a fourth, Delta-variant fueled surge that also is producing confounding, confused behaviors that only add to the pandemic’s considerable gloom. The pandemic, which...more

Parker Poe Adams & Bernstein LLP

Permanent Approval of the Pfizer COVID-19 Vaccine May Prompt Employers to Mandate Vaccinations

On Monday, the Food and Drug Administration gave permanent approval to Pfizer’s COVID-19 vaccine. Similar approval of the Moderna vaccine may be forthcoming, with eventual approval of the Johnson & Johnson one-shot...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: Full FDA Approval

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

Quarles & Brady LLP

FDA Approval of Pfizer Vaccine – Everything Prescribers, Pharmacies, & Vaccine Administrators Want to Know & Forgot to Ask

Quarles & Brady LLP on

The U.S. Food and Drug Administration's ("FDA") approval of the Pfizer vaccine under a new brand name, Comirnaty, created a cascade of legal and regulatory issues for prescribers, pharmacies, and other vaccine administrators....more

Maynard Nexsen

FDA Full Approval of Pfizer’s COVID-19 Vaccine: To Mandate or Not to Mandate, That is the Question

Maynard Nexsen on

Over the past year and a half, employers have become all too familiar with various public health agencies and their regulations, recommendations, and preventative measures. For the past several months, a big question for...more

Bricker Graydon LLP

FDA full approval of Pfizer vaccine should reduce risk of employer mandates

Bricker Graydon LLP on

On August 23, 2021, the U.S. Food and Drug Administration (FDA) fully approved the Pfizer vaccine for those 16 and older - the first full approval of the three COVID-19 vaccines available in the U.S. The Moderna and Johnson &...more

Holland & Hart LLP

FDA Fully Approves Pfizer-BioNTech COVID-19 Vaccine: Implications for Employers

Holland & Hart LLP on

Yesterday, the U.S. Food and Drug Administration (FDA) granted “full approval” to the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and older. In other words, the Pfizer-BioNTech vaccine (which will now be...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

FDA’s Full Stamp of Vaccine Approval Delivers Progress, but Issues With Vaccine Passports and Policies Are Looming

On August 23, 2021, the U.S. Food and Drug Administration (FDA) granted full approval to Pfizer’s COVID-19 vaccine. Moderna’s expedited application for full approval is still pending, and Johnson & Johnson plans to submit its...more

Seyfarth Shaw LLP

FDA Grants Full Approval to the Pfizer Vaccine

Seyfarth Shaw LLP on

Seyfarth Synopsis: Today the FDA approved Comirnaty (COVID-19 Vaccine, mRNA), previously known as Pfizer-BioNTech COVID-19 Vaccine, to prevent COVID-19 disease in individuals 16 and older. This could be big news for those on...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

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