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Scientific Research

Gray Reed

Climate Change Contrarians: Saying What Needs To Be Said

Gray Reed on

COP29 is upon us (Perfidy, thy name is the UNIPCC) being held in the greenwashing Republic of Azerbaijan. And ironically, there are dire warnings from some quarters about the methods “anti-science” Donald Trump will deploy to...more

McGlinchey Stafford

EPA Under a Second Trump Presidency: The Good, Bad, and Ugly

McGlinchey Stafford on

A return to the presidency by Donald Trump has raised questions about the future of the U.S. Environmental Protection Agency (EPA) and the broader landscape of environmental policy in the United States. Given Trump’s past...more

Health Care Compliance Association (HCCA)

NIH Disavows China Initiative, Offers ‘Trusted Asians’ Support But Cases, Questions Linger

In recent months, NIH signaled that it, in the words of Director Monica Bertagnolli, understands the “difficult climate for our valued Asian American, Asian immigrant and Asian research colleagues who may feel targeted and...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2024

On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more

Knobbe Martens

Nobel Prize in Medicine Awarded to American Scientists for Discovery of microRNA

Knobbe Martens on

On October 7, 2024, the 2024 Nobel Prize in Physiology or Medicine was jointly awarded to two American scientists, Victor Ambros (of UMass Medical School) and Gary Ruvkun (of Harvard Medical School), for their discovery of...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – Nobel Prize winners, Chinese AI companies target the U.S. market, Amazon’s AI-powered shopping assistance, and...

To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more

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

Better Health Care Newsletter - October 2024

What consumers can do to reduce environmental health threats all around us - It’s a paradox of modern life: We want more and more stuff, and we want to get all of  it faster, cheaper, more conveniently. And yet, does our...more

Troutman Pepper

Navigating the Uncertain Waters of Marijuana Research in the US

Troutman Pepper on

In recent years, federal and state governments have taken action to make marijuana research easier. These actions are a step in the right direction, and researchers operating in the marijuana space must be aware of the...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more

Holland & Knight LLP

HHS Announces Updates to Policies on Research Misconduct

Holland & Knight LLP on

The 2024 Public Health Service (PHS) Policies on Research Misconduct involving PHS-funded research were released by the U.S. Department of Health and Human Services (HHS) through the Office of Research Integrity (ORI) on...more

Cohen Seglias Pallas Greenhall & Furman PC

ORI Unveils Final Rule on Research Misconduct: Key Changes for Institutions and Respondents

On September 12, 2024, the federal Office of Research Integrity (ORI) announced the release of the Department of Health & Human Services’ Final Rule on Public Health Service Policies on Research Misconduct. This marks the...more

Kohrman Jackson & Krantz LLP

The Impact of PubPeer on Scientific Research Misconduct Investigations

Scientists are generally pleased to learn that their papers are being discussed and cited. Discussion on one platform, however, is a cause of consternation: PubPeer.  No scientist wants to learn that their paper is being...more

Health Care Compliance Association (HCCA)

[Virtual Event] Research Compliance Conference - November 12th, 8:00 am - 5:00 pm CT

Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more

Womble Bond Dickinson

Junk Science in the Courtroom: Prevention is Better than Cure

Womble Bond Dickinson on

When scientific evidence is in play, it is often assumed that the most frequently cited articles are published in the most elite journals. However, this is not necessarily true. A journal is ranked according to its impact...more

Womble Bond Dickinson

Longevity Series: Dipping Our Toes in the Fountain of Youth: An Introduction into Longevity Research

Womble Bond Dickinson on

With the advancement in modern medicine, people are living longer than ever. In fact, the average life expectancy has largely risen over the last 40 years, and is predicted to rise to 85 by the year 2060 (US Census:...more

Hogan Lovells

Research security program guidelines: more work for federally-funded research institutions -Universities and academic research...

Hogan Lovells on

The White House Office of Science and Technology Policy (OSTP) has issued long-awaited Guidelines for Research Security Programs at Covered Institutions (“Guidelines”), which outline how federal research agencies must require...more

Goodwin

Common FDA Bioresearch Monitoring (BIMO) Violations: Updates from FY 2023 to Now

Goodwin on

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

Holland & Knight LLP

New Requirements for Research Security Programs Raise the Stakes for Compliance

Holland & Knight LLP on

The National Security Presidential Memorandum-33 (NSPM-33), issued in January 2021, directed federal agencies that fund research and development (R&D) projects to require certain "Covered Institutions" to certify that the...more

Morrison & Foerster LLP - Class Dismissed

New Civil Liberties Alliance Alleges CPSC AND Commissioner Trumka Exceeded Authority And Plans To File Suit

In early May 2024, the New Civil Liberties Alliance (NCLA) notified the U.S. Consumer Product Safety Commission (CPSC) that it intended to file suit against CPSC and CPSC Commissioner Richard Trumka for allegedly violating...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - September 9th - 12th, Las Vegas, NV

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day comprehensive training program with a focus on the topics and issues that affect research compliance professionals. Our faculty of experienced...more

Goodwin

Update on John Hopkins and Merck Pembrolizumab Litigation

Goodwin on

In a decision that issued last week, a Patent Trial and Appeal Board (“PTAB”) panel instituted inter partes review (“IPR”) of a petition filed by Merck Sharp & Dohme LLC (“Merck”) for a patent owned by The Johns Hopkins...more

Womble Bond Dickinson

FDA Updates Guidance on Intentional Genomic Alterations in Animals

Womble Bond Dickinson on

Intentional genomic alterations (IGAs) in animals refer to deliberate changes made to the genetic material of animals. These alterations are designed to introduce, remove or modify specific traits in animals for various...more

Womble Bond Dickinson

The Perils of Junk Science

Womble Bond Dickinson on

We live in an era in which we can instantly obtain copious amounts of information quickly through the internet, and while this has many advantages, it also opens the door for potential problems. Just search for the term “fake...more

Goodwin

Form FDA 483 Response Best Practices Announced by the FDA

Goodwin on

In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency provides some wisdom on best...more

Health Care Compliance Association (HCCA)

NY Medical College Clashes With OIG After Audit Questions $7.5M, PI Salaries, ‘Illegible Signatures’

New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more

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