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Coronavirus/COVID-19 › FDA Approval › Pharmaceutical Industry

Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms... more +
Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms helping to make sense of insurance, employment, tax, securities, M&A, risk management, and every other consideration touched by this crisis. Follow the channel for a daily email brief of the latest and best updates. less -
Goodwin

FDA Approves BLA for Novavax’s COVID-19 Vaccine

Goodwin on

On May 19, Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active immunization against COVID-19 in adults 65 years and older and individuals 12 through 64...more

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

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

McDonnell Boehnen Hulbert & Berghoff LLP

Senators Send Letter to Commerce Secretary Regarding WTO Waiver Compromise

McDonnell Boehnen Hulbert & Berghoff LLP on

Last week, Senators Thom Tillis (R-NC), Tom Cotton (R-AR), and Marsha Blackburn (R-TN) sent a letter to Secretary of Commerce Gina Raimondo (at right) to express their "grave concerns with the so called 'compromise' agreement...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

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

Robinson+Cole Health Law Diagnosis on

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

Parker Poe Adams & Bernstein LLP

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

Parker Poe Adams & Bernstein LLP on

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

Faegre Drinker Biddle & Reath LLP on

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

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

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

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

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

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

Hogan Lovells

Coronavirus: The Hill and the Headlines, June 2021 - Final Issue

Hogan Lovells on

In Washington: Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky urged parents to vaccinate adolescents and teenagers against the coronavirus Friday, adding that COVID-19 can be severe for this age...more

Faegre Drinker Biddle & Reath LLP

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

Faegre Drinker Biddle & Reath LLP on

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

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA revokes...more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

American Conference Institute (ACI) on

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more

Morgan Lewis

FDA’s End-of-Year Gifts: COVID-19 Diagnostic Tests and Collection Devices for Home Use

Morgan Lewis on

The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC...more

Foley & Lardner LLP

Historic FDA Advisory Committee Vote on Pfizer and BioNTech’s COVID -19 Vaccine

Foley & Lardner LLP on

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 17 to 4 with 1 abstention and 1 no vote that based upon the available scientific evidence, the benefits of the Pfizer and BioNTech’s COVID-19 vaccine...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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In Tuesday's Report: a panel discussion on the U.S. election, Americans warned of COVID-19 surge, Moderna files for FDA EUA, Hong Kong proposes corporate rescue bill, new Foreign Direct Investment rules in Spain, the EU moves...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, November 2020 # 12

Hogan Lovells on

In Washington: Wednesday, the House held its leadership elections reelecting Rep. Nancy Pelosi (D-CA) as Speaker of the House by her caucus. Other top Democratic leaders, Majority Leader Steny Hoyer (D-MD) and Majority...more

American Conference Institute (ACI)

[Virtual Event] 25th Annual Conference on Drug & Medical Device Litigation - December 8th - 9th, 8:45 am - 5:45 pm EST

American Conference Institute (ACI) on

Join us as we celebrate the 25th Anniversary of ACI’s Annual Flagship Conference on Drug & Medical Device Litigation! ACI’s Drug and Medical Device Litigation has united the greatest minds of the pharmaceutical and medical...more

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