News & Analysis as of

Supply Chain Regulatory Oversight

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

Cornerstone Research on

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

K&L Gates LLP on

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

The Volkov Law Group on

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

ArentFox Schiff on

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

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

Jones Day

FDA Announces Delayed Enforcement of Looming Supply Chain Requirements for Drugs Until 2024

Jones Day on

With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...more

Nelson Mullins Riley & Scarborough LLP

Two new FDA Drug Supply Chain Security Act Guidances to help Pharmaceutical Supply Chain Partners Comply with the DSCSA’s move to...

The DSCSA, enacted in 2013, requires entities in the pharmaceutical supply chain to implement security measures to prevent the introduction of counterfeit and illegitimate drugs into the market. One of these measures is the...more

Quarles & Brady LLP

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

Quarles & Brady LLP on

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

Troutman Pepper

Tennessee AG Sues More Than 20 PFAS Manufacturers

Troutman Pepper on

Tennessee AG Jonathan Skrmetti is suing more than 20 per- and polyfluoroalkyl substance (PFAS) manufacturers, including 3M and DuPont, seeking injunctive and monetary relief under the state’s public nuisance and uniform...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

White & Case LLP

US de-SPAC & SPAC data & statistics roundup - HI 2022

White & Case LLP on

US de-SPAC M&A deal value has contracted significantly during the first half of 2022, sliding from US$231.31 billion during the buoyant H1 2021 period to just US$26.29 billion for H1 2022. A wider M&A slowdown as a result of...more

Hogan Lovells

Key legal concerns for advanced therapy medicinal product (ATMP) sponsors in Europe

Hogan Lovells on

In recent years we have seen more and more gene and cell therapies coming successfully to market – but many more such candidates have not made it to market, or been unable to obtain sufficient reimbursement. Gene and cell...more

White & Case LLP

US De-SPAC & SPAC data & statistics roundup - Q1 2022

White & Case LLP on

US De-SPAC M&A Commentary - US De-SPAC M&A deal value totaled US$8.13 billion from 16 De-SPAC deals in Q1 2022. This was significantly lower than the record US$155.43 billion of De-SPAC deal value from 81 deals reported at...more

McDermott Will & Emery

Key Takeaways | Keeping the Lights On: Cyber Threat, Vulnerability and Oversight Considerations for the Energy Sector

McDermott Will & Emery on

During the latest webinar in our Energy Transition series, Partners Carl Fleming and Scott Ferber hosted PWC Principals Brad Bauch, US Power and Utilities Cybersecurity & Privacy Leader, and Mark Ray, Cybersecurity & Privacy,...more

White & Case LLP

Policy shifts may signal a new chapter in the story of globalization

White & Case LLP on

Globalization may be evolving, as nations and regions reassert their regulatory powers on a wide range of issues including trade, competition and national security. The economic lessons of COVID-19 and growing concerns about...more

Hogan Lovells

FDA Extends Enforcement Discretion for Several Requirements in FSMA Regulations

Hogan Lovells on

FDA recently issued guidance announcing its intent to exercise enforcement discretion for several specific provisions in the agency’s regulations implementing the FDA Food Safety Modernization Act (FSMA). The guidance is...more

Epstein Becker & Green

FDA Releases Proposed Rule on National Standards for Drug Wholesaler Licensure

On February 4, 2022—more than six years after the deadline imposed by statute—the U.S. Food and Drug Administration (“FDA”) issued a proposed rule titled “National Standards for the Licensure of Wholesale Drug Distributors...more

Sheppard Mullin Richter & Hampton LLP

Corporate Offtake Agreements are a Driving Force Behind the Shift Toward Renewable Energy in the United States

Continued commitments to renewable generation in 2021 mean that corporate purchasers remain major drivers in the development of new wind and solar power generation projects in the United States. Megawatt numbers vary...more

Hogan Lovells

USDA to invest US$4 billion to strengthen food systems and improve supply chains

Hogan Lovells on

The U.S. Department of Agriculture (USDA or the department) recently announced plans to invest more than US$4 billion to strengthen critical supply chains under President Biden’s “Build Back Better” initiative....more

Foley Hoag LLP - Security, Privacy and the...

The Government’s Swift Response to Pipeline Cyberattack: Executive Order and TSA Security Directive

On May 10, 2021, the hacking group DarkSide succeeded in shutting down the Colonial Pipeline with a ransomware attack that highlighted the vulnerability of the U.S. energy sector to cyberattacks. The attack led to a panic...more

McDermott Will & Emery

An Update on UK and EU REACH Registrations Post-Brexit

McDermott Will & Emery on

The April 30 2021 deadline for UK based companies to grandfather their EU REACH registrations is fast approaching. Companies who have not yet started the grandfathering process should do so immediately or they will not be...more

Stinson - Government Contracting Matters

Continuing Developments on the Supply Chain Front

Recent weeks have brought news on multiple fronts regarding supply chain risks and actions in response thereto: Commerce ICTS Regulations to Go Into Effect; Chinese ICTS Companies, Products and Services in the...more

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