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Regulatory Requirements Regulatory Oversight Supply Chain

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

Morgan Lewis on

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?

Husch Blackwell LLP on

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

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

Husch Blackwell LLP on

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

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

J.S. Held

2024 J.S. Held Global Risk Report: Environmental, Social & Corporate Governance (ESG)

J.S. Held on

The extraterritorial expansion of ESG laws and policies will reach a significant turning point in 2024. Investors, government regulators, and consumers are demanding greater transparency and disclosure when it comes to a...more

Quarles & Brady LLP

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

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On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Hogan Lovells

FDA Provides Update on Forthcoming New Era of Smarter Food Safety Blueprint

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The U.S. Food and Drug Administration (FDA) recently provided an update from FDA Commissioner Stephen Hahn M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas on the forthcoming New Era of Smarter Food...more

Robins Kaplan LLP

Financial Daily Dose 12.04.2019 | Top Story: Google Co-founders Step Down From Executive Roles at Parent Alphabet

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Google announced late Tuesday that co-founders Larry Page and Sergey Brin are “stepping down from executive roles at Google’s parent company, Alphabet.” Google CEO Sundar Pichai will now helm both operations, while Page and...more

Hogan Lovells

FDA Releases Strategy for the Safety of Imported Food

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The U.S. Food and Drug Administration (FDA) recently released the “FDA Strategy for the Safety of Imported Food” (the Strategy), which outlines the agency’s approach to ensuring the safety of the ever-rising volume of...more

Hogan Lovells

Legislative and Regulatory Update on Federal Supply Chain Risk Management

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The U.S. Government is renewing its focus on mitigating technological risks by regulating the supply chain for various goods and services. ...more

Seyfarth Shaw LLP

Outsourcing: Why The Game Has Changed

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Traditionally, alternative labour models – including outsourcing and contracting – have been used by business to defray cost and risk and deal with workflow fluctuations. Today’s environment is creating new challenges for...more

Seyfarth Shaw LLP

Modern Slavery Bill 2018: An Action Plan

Seyfarth Shaw LLP on

The introduction of the Commonwealth Modern Slavery Bill 2018 on 28 June 2018 sets an imperative for businesses operating in Australia to know, and show, how they are identifying and addressing the risks of modern slavery....more

Hogan Lovells

Australia set to join the global fight against modern slavery

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The world is slowly taking action against modern slavery. Since the UK introduced the Modern Slavery Act (“the UK Act“) in 2015, a number of countries have followed suit with their own legislative initiatives. The latest...more

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