News & Analysis as of

Emergency Use Authorization (EUA) Biologics

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

Hogan Lovells

After the Public Health Emergency: FDA plans to revise COVID-19 EUA policies

Hogan Lovells on

On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will be revised to temporarily remain in effect,...more

MoFo Life Sciences

EUAs And The FDA’S Fight Against COVID-19: An Evolving Landscape

MoFo Life Sciences on

The outbreak of the COVID-19 pandemic in 2020 spurred rapid medical and technological innovation, leading to new medicines and devices designed in response to the virus. Under the traditional U.S. Food and Drug Administration...more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year! (Part 3 of 3)

In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug...more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year! (Part 2 of 3)

Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over...more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year!

What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was...more

BakerHostetler

COVID-19 Vaccine: Approval or Authorization?

BakerHostetler on

On Dec. 11, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine for the prevention of the coronavirus disease 2019 (COVID-19). An EUA differs from an approval in that...more

Health Care Compliance Association (HCCA)

CMS Hikes Payment for COVID-19 Inpatients Treated With New Drugs, Links it to 20% Bonus

Report on Medicare Compliance 29, no. 39 (November 2, 2020) - CMS said Oct. 28 that Medicare will pay hospitals extra when they treat inpatients with drugs or biologicals approved by the Food and Drug Administration (FDA)...more

Mintz - Health Care Viewpoints

Bioethics in a Pandemic: FDA Guidance on Granting EUAs for a COVID-19 Vaccine

Earlier this month, the FDA’s Center for Biologics Evaluation and Research issued its highly anticipated guidance outlining the agency’s current thinking on granting emergency use authorization (EUA) to investigational...more

Patterson Belknap Webb & Tyler LLP

The FDA Regulatory Landscape for Covid-19 Treatments and Vaccine (Updated #2)

September 17, 2020 Update: The Trump administration is currently considering accelerating the approval of an experimental Covid-19 vaccine being developed by Oxford University and AstraZeneca. In line with FDA’s June 2020...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....more

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