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MG+M The Law Firm

PFAS and Diabetes: Association Without Causation

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Given ongoing concerns surrounding exposure to per- and polyfluoroalkyl substances (PFAS) and potential adverse human health effects, researchers recently examined whether PFAS exposure could contribute to an increased risk...more

Fenwick & West LLP

The Gates Foundation’s $2.5B Investment Signals a Boost for Women’s Health

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In one of the largest philanthropic initiatives ever dedicated to women’s health, the Gates Foundation announced a $2.5 billion commitment to close long-standing gaps in care, research, investments and data collection focused...more

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

Better Health Care Newsletter - August 2025

Has this ever happened to you? Misplacing your reading glasses, almost daily? Forgetting names, even of good friends and colleagues? Puzzling over why you just walked into the kitchen? Spending a big part of each day...more

Gardner Law

The Value of MDUFA

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Anyone who has submitted a medical device for pre-market review knows the financial investment it takes to for FDA to conduct its review. Under the Medical Device User Fee Amendments (MDUFA), certain submissions, including...more

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

Better Health Care Newsletter - July 2025

With 10,000 baby boomers turning 65 each day, it’s not hard to see why aging well — even spectacularly well — has become a leading obsession of our era. The good news is that yes, there are practical ways to extend life,...more

BCLP

IARC Classifies Automotive Gasoline as Carcinogenic to Humans

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The International Agency for Research on Cancer (IARC)—a branch of the World Health Organization mandated to investigate potential causes of cancer—conducts its own hazard evaluations of suspected carcinogens and publishes...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney...

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In this powerful episode, hosts Heather and Matthew are joined by Sydney Severance, a young woman and former competitive athlete whose life changed dramatically when she unexpectedly became wheelchair-bound. After a...more

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

Better Health Care Newsletter - May 2025

Great thinkers have sought for centuries to convey a crucial truth about humanity’s interconnection. As the poet John Donne wrote: “No man is an island, entire of itself; every man is a piece of the continent, a part of the...more

Foley & Lardner LLP

New Mexico Becomes Third State in the U.S. to Legalize Access to Psilocybin

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On April 7, 2025, New Mexico Governor Michelle Lujan Grisham signed into law SB-219, the Medical Psilocybin Act (the Act), making New Mexico the third state in the country to create a legal pathway for patients to access...more

Butler Snow LLP

Turnabout is Fair Play – “Junk Science” Litigation Aftermath: Requisite Retractions and Dubious Do-Overs

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Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more

Holland & Knight LLP

Nationwide Preliminary Injunction Halts NIH Indirect Cost Rate Change Notice

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Judge Angel Kelley of the U.S. District Court for the District of Massachusetts on March 12, 2025, issued a nationwide preliminary injunction halting the implementation, application or enforcement of the National Institutes...more

Holland & Knight LLP

Holland & Knight Health Dose: March 4, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - February 2025 #3

News Briefs - Proposed Budget Cuts Could Greatly Impact Healthcare Sector - House Republicans unveiled a budget resolution that asks the Energy and Commerce Committee, which oversees Medicare and Medicaid, to find $880...more

Benesch

Dialysis & Nephrology Digest - February 2025

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A New Hope in Kidney Transplants: The Promise of Xenotransplantation - Joe’s struggle for a kidney transplant highlights a dire reality: donor shortages are leaving countless patients in limbo. Enter Dr. PK, a pioneering...more

Holland & Knight LLP

NIH Cuts Research Funding for Indirect Costs

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The National Institutes of Health (NIH) published guidance late on Feb. 7, 2025, setting the indirect cost rate for NIH grants at 15 percent, replacing the negotiated indirect cost rates at many universities, which typically...more

Akin Gump Strauss Hauer & Feld LLP

Just Prior to Leadership Change, FDA Announces Public Workshops to Advance Dialogues on HCT Product Development and Optimizing...

In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high...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

Womble Bond Dickinson

FDA Updates Guidance on Intentional Genomic Alterations in Animals

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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

Morgan Lewis

Legal Considerations for WHO’s ‘Possibly Carcinogenic’ Aspartame Classification

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On July 14, 2023, the World Health Organization (WHO) published a summary of two findings regarding aspartame, an artificial sweetener found in many consumer products. One finding categorized aspartame as “possibly...more

Latham & Watkins LLP

The European Health Data Space - Panacea or Poison Pill?

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On 3 May 2022, the European Commission launched its proposal for a Regulation for the European Health Data Space to “unleash the full potential of health data”. However, questions arise as to whether this proposal is a...more

Holland & Knight LLP

Podcast - Talking Sickle Cell Trait with NFL Wide Receiver Ty Montgomery and Dr. Anjulika Chawla, MD, FAAP

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In honor of National Sickle Cell Awareness Month, Holland & Knight's Public Policy & Regulation Group is proud to partner with the Black Women's Health Imperative for a four-part podcast series on sickle cell disease. Sickle...more

Faegre Drinker Biddle & Reath LLP

Long-Awaited 21st Century Cures Act 2.0 Draft Released

Following months of anticipation by stakeholders including patient organizations, research institutions and medical product developers, Representatives Fred Upton (R-MI) and Diana DeGette (D-DO) released a 21st Century Cures...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more

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

Better Healthcare Newsletter from Patrick Malone - September 2020

Will it be a shot in the arm — or the foot? Americans have invested high hopes in a Covid-19 vaccine. Its development is racing ahead, with researchers deploying novel approaches and governments spending billions of dollars...more

McDermott Will & Schulte

[Webinar] Around the Corner: Evolving Opportunities and Challenges for Real-World Evidence and Data-Powered Solutions - August...

Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models....more

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