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BakerHostetler

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

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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

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

DLA Piper

FAA Issues Final MOSAIC Rule: Key Updates and Changes

DLA Piper on

The Federal Aviation Administration (FAA) released an unpublished version of the Modernization of Special Airworthiness Certification (MOSAIC) rule on July 22, 2025. The rule will become effective 90 days after publication in...more

Gardner Law

FDA Signals Interest in Defining Ultraprocessed Foods

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In June 2025, the U.S. Food and Drug Administration announced it is evaluating whether to formally define the term ultraprocessed food (UPF)—a move that could influence future labeling regulations, public health guidance, and...more

Bergeson & Campbell, P.C.

MDEP Receives 11 CUU Proposals for Products Containing Intentionally Added PFAS Scheduled for Prohibition in 2026, Recommends Two...

As reported in our April 11, 2025, blog item, applications for currently unavoidable use determinations for products containing intentionally added perfluoroalkyl and polyfluoroalkyl substances (PFAS) and scheduled to be...more

Hogan Lovells

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

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The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

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In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

Littler

OSHA Renews its National Emphasis Program on Amputations in the Manufacturing Industry

Littler on

The U.S. Department of Labor’s Occupational Safety and Health Administration renewed its National Emphasis Program on Amputations in Manufacturing Industries (NEP) on June 27, 2025, superseding the prior version. This new NEP...more

Holland & Hart LLP

The July 1 Deadline Approaches for Participation in the Colorado Extended Producer Responsibility (EPR) Program

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Beginning July 1, 2025, producers of a wide range of packaging and paper materials, as well as products that use such materials, are prohibited from selling or distributing such products in the state of Colorado, unless they...more

Akin Gump Strauss Hauer & Feld LLP

Minnesota to Delay PFAS Reporting Deadline

Earlier this week, the Minnesota Pollution Control Agency (MPCA) announced it will extend the upcoming reporting deadline under the state’s PFAS-in-Products law. As currently written, the law requires manufacturers of...more

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

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In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...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

Hogan Lovells

Be vigilant: new post-market surveillance requirements for medical devices in Great Britain take effect

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The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (PMSR), which were passed into law on 22 October 2024, came into force today (16 June 2025), amending the UK’s Medical...more

Bergeson & Campbell, P.C.

Chemical Product Law and Supply: A Guide to New TSCA

Hello, this is Lynn Bergeson. As many of our listeners may know, we here at Bergeson & Campbell, P.C. recently published a book through the American Bar Association’s Section of Environment, Energy, and Resources, titled...more

Shipman & Goodwin LLP

Federal Regulations Arriving ‘PFAShionably Late’ - A CBIA Manufacturing Spotlight Article

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A series of PFAS-related communications and rulemaking from the U.S. Environmental Protection Agency have recalibrated the agency’s focus areas and timeline under the second Trump administration. Federal PFAS regulation...more

Venable LLP

Get Ready for New York's June 1 Registration Deadline for Certain Aerosols

Venable LLP on

By June 1, all entities that supply, manufacture, produce, or distribute aerosol products that contain fluorinated greenhouse gases with a GWP20 greater than 10 (regulated substances), for sale or use in New York, must...more

Husch Blackwell LLP

Minnesota and Lower Potency Hemp Edibles

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On the heels of the 2018 Farm Bill, some states have opted to regulate hemp-derived cannabinoid consumer products. One of the early movers in this area is the State of Minnesota. The regulations in Minnesota for hemp-derived...more

Gardner Law

Staying Prepared Amid FDA Changes

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Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Mayer Brown

Brazil Introduces Regulations on the Importation of Solid Waste and Tailings

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The Brazilian government published Decree No. 12,451/2025 (the “New Decree”), which regulates Article 49, §1 of the National Solid Waste Policy (Law No. 12,305/2010), establishing exceptions to the ban on importing solid...more

Arnall Golden Gregory LLP

Surprise, Surprise: FDA Announces Plans to Increase Number of Unannounced Inspections at Foreign Manufacturing Facilities

In their song, “Surprise, Surprise,” the Rolling Stones lamented about being caught off guard by a disappointing relationship. Sixty years later, foreign manufacturers may face the surprise of an unannounced inspection by the...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

Hogan Lovells

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

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On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. This announcement applies to facilities that produce...more

Morrison & Foerster LLP

New California Law Redefines E-Bikes

California has changed its definition of electric bicycles to clarify ambiguities about the use of throttles. Since their first introduction in the 1990s, electric bicycles, or e-bikes, have grown tremendously in popularity...more

Warner Norcross + Judd

PFAS Regulatory Landscape Continues to Shift: EPA Announces Major Actions and State PFAS Bans Grow

Last week the EPA announced a broad array of agency objectives regarding per‑ and polyfluoroalkyl substances (PFAS) regulation. Although the agency’s announcement was sparing on details, it provides a few key indicators...more

Akin Gump Strauss Hauer & Feld LLP

EPA Speaks on PFAS: What Manufacturers Need to Know

After addressing a number of other programs over the first 100 days of the new administration, on April 28, 2025, the Environmental Protection Agency (EPA) finally addressed PFAS. Administrator Lee Zeldin outlined a number of...more

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