Skip to content
  • logo
  • MoFo Life Sciences
    Because No One is Immune to the Law
Home
AI + Robotics Agtech Announcements Antitrust Asia Bioinformatics Biotech Blockchain CFIUS COVID-19 Corporate + Venture Capital Data Analytics Digital Health Employment European Union FDA Financing Global Healthcare Intellectual Property Licensing + Commercial Litigation Medical Devices + Diagnostics Pharma Privacy + Data Security Product Liability + Class Action Rare Disease Regulatory Startup United Kingdom United States
Editors
About
Subscribe ☰

Topic Archives: COVID-19

June 6, 2022 - COVID-19, FDA, Healthcare, Regulatory

FDA Will Once Again Accept Pre-Submissions for All In Vitro Diagnostic Tests

By: Stacy Cline Amin and Rachel Park

Lindy Pittman, Summer Associate in Washington, D.C., contributed to the drafting of this post. The U.S. Food and Drug Administration (FDA) released a statement on May 31, 2022, that its Center for Devices and Radiological Health (CDRH) will once again be accepting all pre-submissions for …›

February 9, 2022 - COVID-19, Healthcare, United States

DOJ Releases False Claims Act Statistics for Fiscal Year 2021

By: Brian K. Kidd, Adam L. Braverman, and Demme Doufekias

On February 1, 2022, the U.S. Department of Justice (DOJ) announced that it collected more than $5.6 billion in False Claims Act (FCA) settlements and judgments in fiscal year 2021. This is the largest annual total since 2014, and the second largest in FCA …›

December 22, 2021 - COVID-19, FDA, Healthcare, Pharma

Key Takeaways from FDLI’s Enforcement, Litigation, and Compliance Conference Keynote Address

By: Rachel Park

FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the Consumer Protection Branch in 2021, and highlighted areas of …›

September 15, 2021 - COVID-19, Healthcare, Pharma, United States

Is the Future of Telehealth in OIG’s Hands?

Telehealth services may be at a crossroads. While the COVID-19 pandemic brought about widespread adoption of telehealth services, the Department of Justice and the U.S. Department of Health and Human Services Office of Inspector General (OIG) appear primed to audit telehealth services and ramp …›

June 29, 2021 - COVID-19, FDA, Healthcare, Pharma, United States

EUAs and the FDA’s Fight Against COVID-19: An Evolving Landscape

Christine Lentz, a Morrison & Foerster summer associate in our San Diego office, contributed to the writing of this article. 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 …›

May 13, 2021 - COVID-19, FDA, Healthcare, United States

New Face Mask Performance Standard Has Consumers Covered

ASTM International recently approved a new performance standard that will tell consumers just how much protection their cloth face masks offer. Some face coverings like N-95 respirators and surgical masks must meet certain filtration requirements enforced by government agencies like the U.S. Occupational Safety …›

May 11, 2021 - COVID-19, FDA, Healthcare, Pharma, United States

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

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 (produced by Moderna and Johnson & Johnson) have also been …›

March 30, 2021 - COVID-19, FDA, Healthcare, Pharma, United States

Vaccine Production and State Intervention in the U.S.

By: Brigid DeCoursey Bondoc

During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector.[1] State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in Europe. In Italy and Norway, for instance, governments are taking equity stakes …›

March 2, 2021 - COVID-19, European Union, Healthcare, Pharma, United Kingdom

COVID-19: State Intervention in Times of Vaccine Shortages

By: Robert Grohmann

The European Union (“EU”) and its Member States are struggling with the pace of their vaccination programs. This is partly due to shortages of vaccine availability. Germany, like the rest of the EU, is scrambling to obtain vaccine doses as the pharmaceutical industry slows …›

March 1, 2021 - Biotech, COVID-19, FDA, Healthcare, Pharma, Rare Disease, Regulatory

Rare Disease: Sustained Progress in Development Regardless of the Pandemic

By: Catherine M. Polizzi

Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020. In addition, a number of policies implemented in response …›

Post Navigation

« Older Posts
<<
Stay Connected
Topics
Recent Posts
  • EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 3 OF 3)
  • FDA Will Once Again Accept Pre-Submissions for All In Vitro Diagnostic Tests
  • EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 2 OF 3)
  • EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 1 OF 3)
  • Senators Call for Report on State of Psychedelic Research

Unsolicited e-mails and information sent to Morrison & Foerster will not be considered confidential, may be disclosed to others pursuant to our Privacy Policy, may not receive a response, and do not create an attorney-client relationship with Morrison & Foerster. If you are not already a client of Morrison & Foerster, do not include any confidential information in this message. Also, please note that our attorneys do not seek to practice law in any jurisdiction in which they are not properly authorized to do so.

  • Terms of Use
  • Cookies
  • Privacy Policy
  • Disclaimer
  • Attorney Advertising

©1996-2022 Morrison & Foerster LLP.
All Rights Reserved.

Subscribe

Never miss a post from MoFo Life Sciences. Enter your email below to stay up-to-date.