News & Analysis as of

Public Health Compliance

Farella Braun + Martel LLP

Legislation Banning “Forever Chemicals” in Food Packaging in California by 2028 Will Likely Become Law

The California Senate recently passed a bill, SB 682, that would essentially eliminate the use of per-and polyfluoroalkyl substances (PFAS), also known as “forever chemicals,” in food packaging within the state, as of January...more

Sheppard Mullin Richter & Hampton LLP

What Health Equity Means for CON — and Why It Matters Now

Following Sheppard Mullin’s recent webinar on Health Equity Impact Assessments (HEIAs), one thing is clear: providers and investors cannot afford to treat equity requirements as an afterthought in the Certificate of Need...more

Hinshaw & Culbertson - Health Care

Emergency Alert! HHS Restricts Care for Immigrants—Health Centers Must Act Now

Overview of Key Changes and Immediate Impacts - Key Policy Shift: Section 330 Grants now treated as a “Federal Public Benefit” - The U.S. Department of Health and Human Services (HHS) now classifies the Health Center Program...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

Ropes & Gray LLP

Closeout Requirements During Appeals of Terminations of NIH Research Grants

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On July 7, 2025, the National Institutes of Health (NIH) Office of Policy for Extramural Research issued NOT-OD-25-128, titled “Guidance on Enforcement of Closeout Requirements During the Appeals Process” (the Notice). The...more

Arnall Golden Gregory LLP

OPDP is Still Standing: FDA’s Office of Prescription Drug Promotion Issues Two Enforcement Actions Since Recent Layoffs

Taking a note from Sir Elton John’s 1983 hit, “I’m Still Standing,” the Food and Drug Administration’s Office of Prescription Drug Promotion issued two enforcement actions (one Notice of Violation and one Warning Letter)...more

Robins Kaplan LLP

The Robins Kaplan Justice Report - Vol. 19, No. 1 - March 2025

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A recent $2.75 million settlement by Robins Kaplan LLP has drawn attention to a troubling case of deliberate indifference to medical needs at Anoka County Jail (the “Jail”). Deyonta Green, who struggled with addiction issues,...more

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

Akin Gump Strauss Hauer & Feld LLP

HHS, FDA Announce Multiple Initiatives on Food Safety, Quality and Compliance Fronts

In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more

Cozen O'Connor

Democratic AGs Block NIH Grant Cuts

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A coalition of 22 Democratic AGs obtained a preliminary injunction blocking the implementation of the Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates (Rate Change Notice), which would have...more

Fox Rothschild LLP

At Stake - March 13 2025

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The Illinois Gaming Board (IGB) held its monthly meeting on Thursday, March 13, 2025. The meeting was hybrid with in-person accessibility at 160 N. LaSalle St., 5th Floor Auditorium and via livestream. Board members present...more

Stevens & Lee

Urgent Care Centers Must Now Comply With Pennsylvania Newborn Safe Haven Law

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Pennsylvania’s Safe Haven Law, also known as the Newborn Protection Act (the Act), allows parents to surrender their infants at hospitals, EMS providers and police stations without criminal liability, but for a few...more

Ankura

Food Safety and Quality: An Ounce of Prevention is Worth a Pound of Cure

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The consumer-packaged goods and restaurant industries play a crucial role in the global food supply chain, providing a wide variety of food options that consumers rely on for their daily nourishment. However, the integrity of...more

Mintz - Health Care Viewpoints

FDA Continues Push to Improve Food Labeling Practices in the United States

In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more

Foley & Lardner LLP

Make Food “Healthy” Again: FDA’s Resolution for a Healthier 2025

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The U.S. Food and Drug Administration (FDA) began 2025 with a resolution to make food “healthy” again by announcing a trio of new final and proposed rules that are intended to make it easier for consumers to identify healthy...more

ArentFox Schiff

The Top 10 Legal Issues for CFOs and GCs of Fashion and Retail Companies

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In 2025, the retail and fashion industries are bracing for a transformative year, heavily influenced by the policies of the new Trump Administration. These policies promise rapid and significant changes, particularly in areas...more

Morrison & Foerster LLP - Class Dismissed

California Updates Prop 65 Short-Form Warning Requirements

On January 1, 2025, new regulations governing Proposition 65’s so-called safe-harbor warnings went into effect. Proposition 65 requires businesses that employ 10 or more persons to provide “clear and reasonable” warnings on...more

Rivkin Radler LLP

NYS OMIG Publishes 2025 Work Plan

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On January 29, the New York State Office of the Medicaid Inspector General (OMIG) published its 2025 Work Plan, which provides a preview of the OMIG’s program integrity initiatives for the upcoming year. While this post...more

Jackson Lewis P.C.

End of an Era: Cal/OSHA’s COVID Non-Emergency Standard Sunsets

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As of February 3, 2025, most of Cal/OSHA’s COVID-19 Prevention Non-Emergency Standards have officially come to an end. This marks a significant shift for California employers who have been navigating these regulations and...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

Littler

First in, Last out: California’s First-in-Nation COVID-19 Regulation Finally Rides Off into the Sunset (Mostly…)

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Nearly all of the substantive provisions of Cal/OSHA’s non-emergency COVID-19 regulation expired on Monday, February 3, 2025. The event marked a significant end point to the regulatory journey that began on November 19, 2020,...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Drinking Water Enforcement: Arkansas Drinking Water Update Publication Announces Enforcement Orders for Three Water Systems

The Fall 2024 edition of the publication Arkansas Drinking Water Update (“Update”) summarized Enforcement Orders that were issued for three Arkansas water systems. The Update is published by the Engineering Section of...more

Alston & Bird

Health Care Week in Review: OMB Issues and Rescinds Memo Freezing Federal Funds; Senate Finance and HELP Committees Hold HHS...

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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

McDermott Will & Schulte

New York Executive Budget Proposes Patient Consent to Payment Law Updates

The recently released New York State Executive Budget for Fiscal Year 2026 contains proposed revisions to a recently enacted law impacting how healthcare providers obtain patients’ consent to payment. NY Public Health Law...more

Smart & Biggar

Health Canada proposes to amend the Food and Drug Regulations and Medical Devices Regulations to address shortages

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On December 28, 2024, Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to address therapeutic product shortages (see our previous article regarding Health Canada’s...more

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