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Regulatory Oversight Supply Chain

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

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On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance.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

Benesch

Final-Mile Delivery and Nature of Commerce - The Most Important Legal Question Providers Struggle to Answer

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The growth of final-mile package deliveries, especially to residential delivery following the global pandemic, raises important legal questions about the transportation service performed by delivery drivers and their...more

Ropes & Gray LLP

2025 Medtech Regulatory Affairs Roundtable: Key Takeaways

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On May 22, Ropes & Gray and McKinsey & Company co-hosted the 12th Medtech Regulatory Affairs Roundtable online. Around 40 Regulatory Affairs leaders from Chinese and multinational medtech companies gathered to review and...more

Blank Rome LLP

The FMC Announces Investigation into Flags of Convenience and Unfavorable Conditions Created by Flagging Practices

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The U.S. Federal Maritime Commission (“FMC”) announced on May 21, 2025 that it is initiating a non-adjudicatory investigation into whether the: 1) vessel flagging laws, regulations, and/or practices of certain foreign...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

Morgan Lewis

From Offshore to Onshore: Considerations for Pharmaceutical Industry Stakeholders Amid New Domestic Drug Manufacturing EO

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The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...more

Husch Blackwell LLP

Is Alcohol-Style Federal Regulation Coming for THC Beverages?

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Unless you’ve been living under a rock, you know that “THC beverages” derived from hemp have exploded across America (at least in states where they are allowed by law). Time and again, due to the legal ambiguities and...more

Morgan Lewis - As Prescribed

Distribution Chain Compliance for Medical Devices

Distributors, dispensers, and retailers of medical device products face a patchwork of federal and state requirements governing distribution chain compliance. Given the evolving and expanding requirements for device...more

Morrison & Foerster LLP

So Long, CPSC?

The Trump administration may eliminate the Consumer Product Safety Commission (CPSC), according to a recently leaked draft fiscal year 2026 budget for the Department of Health and Human Services (HHS). This “pre-decisional”...more

Hogan Lovells

The Cyber Security and Resilience Bill

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On 1 April 2025, the UK Department for Science, Innovation and Technology issued a policy statement setting out its key proposals for the new Cyber Security and Resilience Bill. The Bill is intended to respond to an...more

Morgan Lewis

HHS Signals GRAS Reform: How Food Manufacturers Can Prepare Now

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Ingredient suppliers and food manufacturers face an uncertain supply chain landscape in which “generally recognized as safe” (GRAS) self-determinations may be more closely scrutinized. The US Department of Health and Human...more

Jones Day

Chemical Recycling Still Faces Regulatory Challenges in the EU

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Chemical recycling of plastic is at a turning point in Europe, with several large projects poised to start but still facing regulatory and market challenges. As highlighted in the study recently published by consultants...more

Morgan Lewis

Key Considerations for Foreign Clinical Trials When Looking Abroad for Product Development

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With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development impacts. While these cuts...more

Husch Blackwell LLP

Say Goodbye to the Red Dye: Legal Implications Following the FDA’s Recent Ban

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On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As...more

Wiley Rein LLP

[Podcast] The Impact of IoT Supply Chain Risks on Government Contracts

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In this episode of Wiley’s Government Contracts podcast, partners Tracye Howard and Sara Baxenberg discuss the evolving national security concerns surrounding Internet of Things (IoT) modules produced by Chinese companies...more

Orrick, Herrington & Sutcliffe LLP

FINRA publishes its 2025 Regulatory Oversight Report

On January 28, FINRA published its 2025 FINRA Regulatory Oversight Report, which highlights areas identifying compliance gaps and observing emerging risks. The report introduced new topics such as the third-party risk...more

Clark Hill PLC

The Learned Concierge - December 2024, Vol. 15

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The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more

Epstein Becker & Green

Recent Supreme Court Decisions and the DSCSA

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The recent Supreme Court decisions of SEC v. Jarkesy and Loper Bright Enterprises v. Raimondo have the potential to meaningfully impact the implementation and enforcement of the Drug Supply Chain Security Act (“DSCSA”) as...more

Cornerstone Research

2024 TEC Institute Summit: Key Insights and Takeaways

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The inaugural TEC Institute Summit took place on 24 April 2024, organised in collaboration with Cornerstone Research and the European University Institute’s Centre for a Digital Society. Policymakers, technological...more

K&L Gates LLP

Doing Business in Australia

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Australia welcomes new business and foreign investment by providing a strong economy, a stable political environment and a skilled and talented workforce. Our comprehensive guide to Doing Business in Australia has been...more

Womble Bond Dickinson

Permitting Reform in the United States

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This article is part of Womble Bond Dickinson’s Energy & Natural Resources thought leadership series titled Striking the Balance: Permitting Reforms for Mining and the Energy Transition. In this series, we’ll explore the...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Meteoric Rise of Generative AI Has Regulators Gearing Up To Preserve Competition

Key Points Artificial intelligence (AI) — and in particular generative AI, which creates new content — has recently emerged as a transformative tool with the power and potential to reshape familiar industries. Although...more

The Volkov Law Group

A Deeper Dive into Supply Chain Transparency & Accountability

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The sheer proliferation of supply chain transparency and accountability regulations at international scale itself warrants a closer look at the level of scrutiny required of organizations with complex, multi-faceted, global,...more

ArentFox Schiff

Navigating the Complexities of Forced Labor Laws: ArentFox Schiff's 2024 Guide for Global Businesses

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In the last few years, changes to the United States enforcement stance on the forced labor import ban authorized by 19 U.S.C. § 1307 and passage of the Uyghur Forced Labor Prevention Act (UFLPA) have fundamentally changed the...more

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