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Holland & Knight LLP

FDA Enforcement Against Dental Lab Could Have Broader Implications

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The U.S. Food and Drug Administration (FDA) recently published a warning letter (Warning Letter) targeting a dental laboratory after a lengthy inspection found that the dental laboratory's operations, which offer...more

ArentFox Schiff

Federal Court Blocks Prop 65 Warning for Titanium Dioxide in Cosmetics

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In an order filed on August 12, the US District Court for the Eastern District of California ruled that California’s Proposition 65 cancer warning requirement for certain listed forms of titanium dioxide (airborne, unbound...more

McDermott Will & Schulte

MHRA announces changes to international reliance and in vitro diagnostic devices rules

In late July 2025, the UK government published its response to a consultation held between November 2024 and January 2025 about international reliance, UK Conformity Assessed (UKCA) marking and in vitro diagnostic devices. In...more

McGuireWoods LLP

Product Liability & Mass Tort Monitor: September 2025

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The Product Liability & Mass Tort Monitor is a monthly newsletter delivering critical updates, data insights and actionable strategies for navigating the complexities of product liability and mass tort litigation....more

Hinch Newman LLP

How to Avoid Scrutiny When Advertising or Labeling Made in USA

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In 1997, following consumer research and public comments, the FTC published an Enforcement Policy Statement on U.S. Origin Claims to guide marketers and manufacturers that want to make an unqualified Made in USA claim under...more

BCLP

PFAS in Consumer Products: State-by-State Regulations - September 2025

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Manufacturers, distributors, and retailers of consumer products across a broad spectrum of industries are being impacted by state laws regulating the presence of per- and polyfluoroalkyl substances (“PFAS”) in their products....more

Greenberg Glusker LLP

Counting to 10: Simpler in Kindergarten than in Proposition 65

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California’s Proposition 65 (“Prop. 65”) requires businesses to provide warnings for any products that contain certain levels of chemicals determined by the State of California to cause cancer or reproductive harm. Prop. 65...more

Arnall Golden Gregory LLP

Made in America? What Developers Need to Know About U.S. Supplement Facilities

Introduction - “Made in America” has strong consumer appeal, but in the dietary supplement industry, reality is far more complex. Roughly 75-80% of raw nutraceutical ingredients (like vitamin C, fish oils, amino acids, and...more

Goodwin

Lupin Announces Licensing Deal with Sandoz for Ranibizumab Biosimilar

Goodwin on

On August 12, 2025, Lupin Limited (“Lupin”) announced that it has partnered with Sandoz Group AG (“Sandoz”) to market and commercialize Lupin’s biosimilar ranibizumab across multiple regions. Ranibizumab is a recombinant...more

Womble Bond Dickinson

A Guide for the Registration of Manufacturers and Distributors of Associated Equipment in Nevada

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Unlike the approval process for many aspects of Nevada gaming, manufacturers and distributors of associated equipment are not required to be found suitable or licensed by the Nevada Gaming Control Board (“Board”) and the...more

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

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The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Hogan Lovells

The new European Accessibility Act (EAA)

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The EAA (i.e., Directive (EU) 2019/882) aims at improving the accessibility of certain products and/or services across the EU. It seeks to harmonize accessibility requirements, ensuring that people with disabilities can fully...more

BCLP

What is the European Accessibility Act and What Impact Will It Have on Your Business?

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The European Accessibility Act (EAA) came into force on 28 June 2025. It requires that all in-scope products and services placed on the market or provided after that date in the EU must meet specified accessibility...more

Paul Hastings LLP

White House and DoD Unleash New Directives on Drones

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The White House and Department of Defense (DoD) have announced a series of new directives that will significantly impact the burgeoning domestic drone industry. This initiative, titled “Unleashing American Drone Dominance,”...more

Cozen O'Connor

FDA Encourages Food Manufacturers to Phase Out FD&C Red No. 3 Ahead of 2027 Deadline

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On July 14, 2025, the Food and Drug Administration (FDA) issued new guidance encouraging food manufacturers to phase out FD&C Red No. 3 ahead of the previous 2027 deadline and “as soon as is practicably possible.” Recall...more

Paul Hastings LLP

CMS Proposes Major ASP Reporting Overhaul — Implications for Fair Market Value and Bona Fide Service Fees

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The Centers for Medicare & Medicaid Services (CMS) recently published its Proposed 2026 Physician Fee Schedule Rule (Proposed Rule), with extensive implications for drug pricing, Average Sales Price (ASP) calculations, and...more

BakerHostetler

FDA’s ‘PreCheck’ Program: New Pathway to Acceleration of US Drug Manufacturing

BakerHostetler on

The U.S. Food and Drug Administration (FDA) has announced FDA “PreCheck,” a new regulatory program intended to streamline the development and approval of domestic pharmaceutical manufacturing facilities. ...more

Holland & Knight LLP

PFAS in Cosmetics: State-Led Regulatory Surge Demands Proactive Compliance

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States are rapidly enacting and implementing bans and reporting requirements for per- and polyfluoroalkyl substances (PFAS) in cosmetics, creating a complex and evolving compliance environment for manufacturers, distributors,...more

Husch Blackwell LLP

NHTSA Grants First-Ever U.S. Exemption for Purpose-Built Robotaxi Fleet: Key Takeaways for the AV Industry

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The National Highway Traffic Safety Administration (NHTSA) has granted Amazon’s Zoox Inc. a landmark exemption for its U.S.-manufactured, purpose-built autonomous vehicles (AVs). This decision allows Zoox to deploy robotaxis...more

Bergeson & Campbell, P.C.

EPA Issues Final SNUR for Graphene Nanoplatelets (Generic)

On July 29, 2025, the U.S. Environmental Protection Agency (EPA) issued final significant use rules (SNUR) for certain chemical substances, including graphene nanoplatelets (generic), that were the subject of premanufacture...more

Akin Gump Strauss Hauer & Feld LLP

FDA Moves Forward on Fluoropolymers

On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical...more

Hinch Newman LLP

Essential Guide to FTC Made in USA Advertising Do’s and Don’ts | FTC Made in USA Attorney

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The Federal Trade Commission recently enacted the Made in USA Labeling Rule and updated its “Complying with the Made in USA Standard” business guidance. Both reinforce the “all or virtually all” standard...more

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

Orrick, Herrington & Sutcliffe LLP

Will FDA’s Warning Letter to WHOOP Put a Chill on Wearables?

FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the...more

Hogan Lovells

Key takeaways – UK MHRA’s response to consultation on ‘Medical Devices Regulations: Routes to market and in vitro diagnostic...

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more

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