News & Analysis as of

Public Health Life Sciences Coronavirus/COVID-19

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 229: Public Health in South Carolina with Dr. Edward...

Maynard Nexsen on

This week, our hosts Heather and Matthew welcome Dr. Edward Simmer, the Interim Director of the South Carolina Department of Public Health. After leading DHEC through the latter half of the COVID pandemic and its transition...more

Sheppard Mullin Richter & Hampton LLP

FDA Dumps Trio of Device-Related Guidances Prior to Administration Change

Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more

Alston & Bird

Health Care Week in Review: House Held a Markup of 23 Bills; Senators Announced a Proposal on Primary Care Payment Reform

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Paul Hastings LLP

Post-COVID Checkup: Current FDA Due Diligence Considerations

Paul Hastings LLP on

The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more

Knobbe Martens

FDA Updates Medical Device Shortages List

Knobbe Martens on

The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more

MoFo Life Sciences

New Opportunities For Test Developers: Monkeypox Diagnostics

MoFo Life Sciences on

For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products....more

Knobbe Martens

WTO Agrees to Partial Patent Waiver for COVID-19 Vaccines

Knobbe Martens on

On June 16, 2022, the World Trade Organization (WTO) agreed to a partial waiver of intellectual property rights related to COVID-19 vaccines. The agreement came on the heels of an all-night negotiating session. The agreement...more

MoFo Life Sciences

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

MoFo Life Sciences on

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 all in vitro diagnostic (IVD)...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: New Guidance on Measuring Severity Anticipated

As vaccination rates drop to an all-time low in the United States, the CDC is preparing new guidance on measuring the severity of outbreaks in our communities. Meanwhile, a study on the impact of hospitalization on the mental...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

Knobbe Martens

Researchers Develop Face Mask for Detection of SARS-CoV-2

Knobbe Martens on

According to an article published in Nature Biotechnology, Harvard and MIT researchers invented a face mask for detecting SARS-CoV-2, the virus that causes COVID-19, via a user’s breath.  Instead of relying on a lab, the...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, May 2021 # 4

Hogan Lovells on

In Washington: The Food and Drug Administration (FDA) has authorized the use of the Pfizer vaccine for 12 - 15 years old. An advisory committee of the Centers for Disease Control and Prevention is expected to meet shortly to...more

Hogan Lovells

The TGA and the Iron Mask

Hogan Lovells on

In 2020, heightened demand for health care resulted in an influx of therapeutic goods being included on the Australian Register of Therapeutic Goods (ARTG). A large portion of these goods are manufactured in China however,...more

Morgan Lewis

Vaccine Development and Distribution: Legal Considerations for US Healthcare Providers and Other Employers

Morgan Lewis on

As the United States races to deliver safe and effective coronavirus (COVID-19) vaccines under the Biden administration, employers, healthcare providers, and many others are assessing what it means for their industries and...more

Bricker Graydon LLP

ODH issues guidance on redistributing COVID-19 vaccine doses

Bricker Graydon LLP on

On January 15, 2021, the Ohio Department of Health (ODH) released COVID-19 Vaccine Redistribution Guidance for enrolled COVID-19 vaccine providers....more

Womble Bond Dickinson

Do You Need To Extend Your “Dry January”?

Womble Bond Dickinson on

Was one of your New Year’s resolutions to participate in “Dry January”? Have you been able to refrain from drinking since January 1? Are you considering getting the COVID vaccine?...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 5

Hogan Lovells on

In Washington: The White House Coronavirus Task Force is warning that there may be a new fast-spreading U.S.A. variant of the coronavirus. "This fall/winter surge has been at nearly twice the rate of rise of cases as the...more

Bricker Graydon LLP

Providers should account for extra doses of COVID-19 vaccines in their vaccination plans

Bricker Graydon LLP on

Ohio has been receiving shipments of COVID-19 vaccines since the U.S. Food and Drug Administration (FDA) granted authorization for emergency use in December 2020....more

Jackson Walker

Unpacking the COVID-19 Vaccine Distribution: A Bright Spot During a Dark Winter

Jackson Walker on

In the waning days of autumn, it appeared that Texas was destined for a dark winter. As recently as December 14, 2020, the Texas Department of State Health Services (DSHS) reported over 1.3 million confirmed cases of...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

Herbert Smith Freehills Kramer

Third-Generation Vaccines Take Center Stage in Battle Against COVID-19

The biopharmaceutical industry is at the forefront of COVID-19 news due to major advances in vaccine development. Now, more than a year since the first case of COVID-19 and nearing a year since daily life has been upended by...more

Hogan Lovells

[Webinar] Looking ahead to 2021: Impacts of the election for the life sciences and health care industry - November 19th, 12:30 pm...

Hogan Lovells on

Life Sciences and Health Care Horizons virtual event series - The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more

Mintz - Health Care Viewpoints

Bioethics in a Pandemic: Final Framework for Equitable Allocation of a COVID-19 Vaccine

Earlier this month, the National Academies Committee on Equitable Allocation of Vaccine for the Novel Coronavirus released its Final Framework to guide US distribution and administration of a COVID-19 vaccine, once available....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

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – September 2020 # 6

Hogan Lovells on

In Washington - The House of Representatives returns from recess this week to join the Senate colleagues for the final work period before they adjourn in mid-October for the November elections. The likelihood of a deal on...more

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