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Supply Chain Regulatory Requirements Manufacturers

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

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

Hogan Lovells

Securing supply in disruptive times – Ways to set up and adapt strategic sourcing agreements

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Driven by transformation trends and geopolitical volatilities, companies must reshape their sourcing strategies. Across all manufacturing sectors the focus is shifting towards securing access to vital technologies and scarce...more

BakerHostetler

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Industry Perspective

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Supply chain disruptions have become a significant challenge for the U.S. FDA-regulated products industry, affecting the availability of pharmaceuticals, medical devices, and food. These disruptions are caused by various...more

Bergeson & Campbell, P.C.

DOD Publishes 2025 Update on Critical PFAS Uses, Recommends Risk-Based Approach to Defining PFAS

The U.S. Department of Defense (DOD) has published a July 2025 report entitled Update on Critical Per- and Polyfluoroalkyl Substance Uses. House Report 118-121, which accompanied the 2024 DOD appropriations bill (H.R. 4365),...more

Eversheds Sutherland (US) LLP

Global Supply Chain Horizons - July 2025

Welcome to the latest edition of our quarterly global supply chain horizons providing you with a update on the key developments from around the world. Cross-Border - China and the US trade deal - On June 27, the PRC...more

Holland & Knight LLP

California's Microplastics Proposal: Impacts on the Consumer Products Supply Chain: The Proposed Listing of Microplastics Reflects...

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California's Department of Toxic Substances Control (DTSC) has proposed listing microplastics on its "Candidate Chemicals List" under the Safer Consumer Products (SCP) Program, a regulatory framework designed to reduce toxic...more

Pillsbury Winthrop Shaw Pittman LLP

Plasticizer PIP (3:1) Ban Is Still a Year Away, but Affected Companies Should Act Today

After October 31, 2026, the distribution in commerce of articles containing PIP (3:1) will be prohibited. Affected companies must phase out the production of PIP (3:1) articles and sell or otherwise remove current inventory....more

Jones Day

The EU's Deforestation Regulation: Will There Be Further Changes?

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The EU's Deforestation Regulation (EUDR), designed to ensure that no products that contribute to deforestation are sold in, or exported from, the EU, continues to be criticized by EU Member States and major market players....more

Bergeson & Campbell, P.C.

OECD Publishes Report on Commercial Availability and Current Uses of PFAS and Alternatives in Hydraulic Oils and Lubricants

On June 20, 2025, the Organisation for Economic Co-operation and Development (OECD) published a report entitled Per- and Polyfluoroalkyl Substances (PFAS) and Alternatives in Hydraulic Oils and Lubricants: Report on...more

ArentFox Schiff

FDA’s Remote Regulatory Assessments Enhance DSCSA Compliance With Technology-Driven Oversight

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On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more

Gardner Law

What to Do When FDA Detains Your Shipment

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When products in your shipment violate—or appear to violate—FDA laws and regulations, the FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.” This notice is considered the Notice...more

Katten Muchin Rosenman LLP

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

BakerHostetler

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Policy Shifts

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Navigating the complexities of maintaining a stable supply chain in an ever-changing global environment is a key focus for FDA-regulated companies. As US policy shifts, the topic of global supply chain has only become more...more

Womble Bond Dickinson

FCC Proposes to Add Certain Connected Vehicle Technologies to the Covered List

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The Federal Communications Commission’s (FCC or Commission) Public Safety and Homeland Security Bureau (Bureau) and Office of Engineering and Technology (OET) have published a Public Notice seeking input on adding certain...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

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

Bergeson & Campbell, P.C.

Minnesota Extends Public Comment Period on Proposed PFAS Reporting Rule as Entities Voice Concerns about Compliance with Deadlines...

On May 22, 2025, the Minnesota Pollution Control Agency (MPCA) held a public hearing on its “Proposed Permanent Rules Relating to PFAS in Products; Reporting and Fees” (proposed rule). Administrative Law Judge (ALJ) Jim...more

Jones Day

European Commission Proposes Further Prohibitions of Territorial Restrictions on Branded Products

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Future prohibition on territorial supply constraints would expand EU law to prohibit certain unilateral conduct by large manufacturers....more

Bergeson & Campbell, P.C.

EC Announces Low- and High-Risk Countries under the EUDR

The European Commission (EC) released on May 22, 2025, the identity of the countries that present a low or high risk of deforestation in producing seven commodities (cattle, cocoa, coffee, palm oil, rubber, soy, and wood)...more

Foley & Lardner LLP

CPSC Announces “Record-Breaking Week” of Enforcement Actions Against Chinese Manufacturers

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On May 15, 2025, the Consumer Product Safety Commission (CPSC or Commission) announced a “record-breaking week” of enforcement actions against “foreign violators.”[1] Namely, the Commission announced 28 separate product...more

IR Global

How the CHIPS Act Impacts Arizona Manufacturers in 2025: Opportunities and Obligations You Should Know

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The semiconductor industry has exploded in Arizona over the last few years. Whether you're a startup looking to enter the supply chain or a longtime manufacturer hoping to expand your footprint, you’ve likely heard about the...more

McGuireWoods LLP

FDA to Expand Unannounced Inspections of Foreign Facilities — Manufacturers, Research Firms Should Prepare

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On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products...more

Mitratech Holdings, Inc

EU Cyber Resilience Act: How to Prepare Now

The EU Cyber Resilience Act (CRA), adopted by the European Parliament in 2024, marks a major milestone in European cybersecurity legislation. As the first EU-wide law focused on the cybersecurity of digital products, it...more

Cooley LLP

FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities

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On May 6, the US Food and Drug Administration (FDA) announced plans to expand its use of unannounced inspections at foreign manufacturing facilities that “produce foods, essential medicines, and other medical products...more

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