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Mintz - Health Care Viewpoints

FDA in Flux — August 2025 Newsletter

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more

Mintz - Health Care Viewpoints

CMS Proposes New Standards for Bona Fide Service Fees in Average Sales Price Calculations: What Plans, PBMs, and Other Recipients...

The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when calculating Average Sales Price (ASP) for Medicare...more

Pillsbury Winthrop Shaw Pittman LLP

Navigating New Waters: Getting Ahead of Extended Producer Responsibility Laws

Packaging-related EPR laws are rapidly creating complex compliance obligations across multiple states; companies should act to avoid unexpected fees, increased costs and competitive disadvantages....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

Hogan Lovells

OIG issues two unfavorable decisions, cautions against some customer service fees paid by manufacturers

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The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued two unfavorable decisions in Advisory Opinions (AOs) 25-04 and 25-08 (the “Opinions”), finding that some service fees paid by...more

Ballard Spahr LLP

Compliance With State Packaging Extended Producer Responsibility Laws Due by July 1, 2025

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Producers of packaging and other covered products are facing near-term deadlines to pay fees or register for programs intended to subsidize recycling in many states. With an initial fee payment due on July 1, 2025, for more...more

Troutman Pepper Locke

New Mississippi Cigarette and ENDS Directory Laws Take Effect in July

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Effective July 1, Mississippi will require all cigarette and ENDS manufacturers to provide annual certifications and have their products listed on a state directory in order for their products to be sold in the state. The...more

Bradley Arant Boult Cummings LLP

Cloud Control: Alabama’s Newest Nicotine Regulation That’s Just Too “Juicy” to Ignore

On May 14, Alabama Gov. Kay Ivey signed Alabama HB8 into law. Effective June 1, HB8 introduced sweeping changes that will reshape how nicotine products are sold, marketed, and regulated in Alabama. You heard that right,...more

Environmental General Counsel PC

CalRecycle Releases New EPR Packaging Regulations: Imminent Compliance, New Exclusions, and Deferred Eco-Modulation Implementation

A lot is going on in the extended producer responsibility (“EPR”) packaging world this month.  Maryland and Washington became the sixth and seventh states respectively to enact EPR packaging laws.  And this week, just a...more

Tonkon Torp LLP

Packaging EPR Law Enacted in Maryland

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This week Maryland’s Governor Wes Moore signed Senate Bill 901, an Extended Producer Responsibility (EPR) law designed to make “producers” of packaged items and paper products financially responsible for the upgrades to state...more

Bergeson & Campbell, P.C.

Comments on Minnesota’s Proposed Rule for Reporting Products Containing Intentionally Added PFAS Are Due May 21, 2025

With the January 1, 2026, reporting deadline fast approaching for reporting on products containing intentionally added per- and polyfluoroalkyl substances (PFAS), on April 21, 2025, the Minnesota Pollution Control Agency...more

Beveridge & Diamond PC

TSCA Fee Payments for Manufacturers of Five High-Priority Substances

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Companies that manufacture any of five chemicals are facing substantial fee payments under the Toxic Substances Control Act. The U.S. Environmental Protection Agency (EPA) has published preliminary lists of manufacturers that...more

Cozen O'Connor

The State AG Report – 12.19.2024

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Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Illinois AG’s and FTC’s Settlement Takes a $25 Million...more

Seyfarth Shaw LLP

New Jersey Destination Charge Case Reaches Final Destination - Seyfarth's Future of Automotive Series

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On Wednesday, October 23, 2024, FCA US LLC, the manufacturer of Chrysler, Jeep, Dodge, Ram vehicles, among others, put the final nail in the coffin of claims by consumers that “destination charges” for the delivery of...more

Fisher Phillips

Navigating Vietnam’s Labor Revolution: What Employers Need to Know About Potential New Trade Union Law

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As global manufacturers pivot away from China and set their sights on Vietnam, the country’s labor and employment landscape is rapidly changing. This surge in demand from Europe and the U.S. has not only sparked economic...more

Environmental General Counsel PC

EPR Packaging Laws: Oregon's Program Plan Provides Roadmap for Compliance and Producer Fees

On March 31, Circular Action Alliance (“CAA”), the Producer Responsibility Organization (“PRO”) for California, Colorado, and the only contender for PRO in Oregon, submitted the first draft of its Program Plan (“the Plan”)...more

Beveridge & Diamond PC

TSCA Sticker Shock: EPA Proposes Large Fee Increases

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Does your company manufacture domestically or import chemicals that the U.S. Environmental Protection Agency (EPA) is reviewing under section 6 of the Toxic Substances Control Act (TSCA)? Does your company submit applications...more

Wiley Rein LLP

EPA’s 18.9% TSCA Fee Inflation Adjustment

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Amid historic and massive increases in inflation[1] and unprecedented supply chain challenges, the Environmental Protection Agency (EPA or Agency) raised its Toxic Substances and Control Act (TSCA) fees by 18.9%. These fees...more

ArentFox Schiff

FDA Announces New Fees for Manufacturers of Over-the-Counter Drugs

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As we explained in a previous alert, one of the lesser-known provisions of the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act was a significant overhaul of the way that most OTC drugs are regulated in...more

Womble Bond Dickinson

FDA Reissues Notice Announcing Increased OTC Monograph Facility Fees

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On March 26, 2021, the FDA updated and reissued the fee rates for the newly created over-the-counter (OTC) monograph Drug User Fee program (OMFUA) for FY2021 in a Federal Register Notice (FRN) titled “Fee Rates under the...more

Sheppard Mullin Richter & Hampton LLP

FDA Announces Facility Fees for OTC Drug Manufacturers

On Friday, March 26, 2021, FDA published a Federal Register notice, “Fee rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing 2021 fee rates under its over-the-counter (OTC)...more

Bergeson & Campbell, P.C.

Comments On Proposed Changes To TSCA Fees Rule Due February 25

On January 11, 2021, EPA published a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule. 86 Fed. Reg. 1890. Under TSCA, EPA collects fees from chemical manufacturers and processors to help...more

Arnall Golden Gregory LLP

OTC Monograph Fees Announced… Not So Fast!

On December 29, 2020, the U.S. Food and Drug Administration published a Federal Register notice setting the fee rates under the Over-the-Counter Monograph User Fee Act (OMUFA) Program for Fiscal Year 2021. Reed Tech...more

Bergeson & Campbell, P.C.

EPA Proposes Updates To TSCA Fees Rule

On December 21, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication notice of proposed updates to the Toxic Substances Control Act (TSCA) Fees Rule. Specifically, the proposed updates to the...more

Wiley Rein LLP

OTC Drug User Facility Fees – Don’t Miss the Changes!

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On January 4, 2021, FDA unexpectedly withdrew the notice entitled Fee Rates Under the Over the Counter Monograph User Fee Program for Fiscal Year 2021 stating that it had been ordered to cease further collection efforts...more

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