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Regulatory Requirements Public Health Compliance

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

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

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

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

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

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 & Emery

New York Executive Budget Proposes Patient Consent to Payment Law Updates

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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

Beveridge & Diamond PC

Environmental Developments to Watch in California in 2025

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As California remains at the forefront of environmental progress and regulation, 2025 will usher in pivotal developments in state-level policies addressing product stewardship, contaminants of concern, climate change, mobile...more

Foley & Lardner LLP

DEA Tightens Buprenorphine Telemedicine Prescribing Rules

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The Drug Enforcement Administration (DEA) and the U.S. Department of Health & Human Services (HHS) just finalized their March 2023 proposed rule regarding telemedicine prescribing of buprenorphine. The final rule, effective...more

Womble Bond Dickinson

FDA Sets Action Levels For Lead

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A year ago, the FDA issued draft guidance for lead levels in baby foods. In the year since the FDA issued its draft guidance for lead levels in baby food, two states, California and Maryland, have adopted laws which require...more

MG+M The Law Firm

EPA Argues PFAS Maximum Contaminant Levels Are Lawful and in Accordance With Statutory Procedure

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On April 10, 2024, the United States Environmental Protection Agency (EPA or Agency) promulgated the first-ever national, legally enforceable maximum contaminant levels (MCLs) for six per- and polyfluoroalkyl substances...more

Husch Blackwell LLP

California’s Proposition 65 Short-Form Warnings Now in Effect

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California’s Office of Environmental Health Hazard Assessment (OEHHA) issued a notice of proposed amendments to Proposition 65 in October 2023 that significantly modify the information businesses are required to provide in...more

McDermott Will & Emery

ASTP Final Rule Codifies Requirements for TEFCA-Qualified Health Information Networks

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On December 16, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more

Bracewell LLP

CSB’s New Transparency Initiative

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On January 14, 2025, the U.S. Chemical Safety and Hazardous Investigation Board (“CSB”) released Volume One of a series of detailed reports on serious accidental chemical incidents reported to CSB under the Accidental Release...more

BakerHostetler

Navigating FDA’s Guidance on Validation and Verification of Analytical Testing Methods for Tobacco Products

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The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides tobacco product...more

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