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Fees Regulatory Requirements Manufacturers

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

Gardner Law on

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

Ballard Spahr LLP

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

Ballard Spahr LLP on

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

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

Beveridge & Diamond PC

TSCA Fee Payments for Manufacturers of Five High-Priority Substances

Beveridge & Diamond PC on

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

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