News & Analysis as of

Supply Chain Regulatory Standards

Akin Gump Strauss Hauer & Feld LLP

EU Ratifies Pioneering Artificial Intelligence Legislation

On May 21, 2024, the European Union finalized the adoption of the groundbreaking EU Artificial Intelligence Act, a comprehensive and sector-agnostic legislation that extends globally. This 420-page Act aims to regulate the...more

NAVEX

GRC Latest News – AI Benefits Your Compliance Program

NAVEX on

Artificial intelligence (AI) is transformative technology that has captured industries worldwide and is here to stay. Defined as a system designed to operate with a certain level of autonomy, AI uses machine learning and...more

Holland & Knight LLP

FERC Approves New Cybersecurity Standards for Low-Impact Electric Assets

Holland & Knight LLP on

At its open monthly meeting on March 16, 2023, the Federal Energy Regulatory Commission (FERC) approved a new cybersecurity standard proposed by the North American Electric Reliability Corporation (NERC) to address the supply...more

Latham & Watkins LLP

European Commission Releases Communication on the Green Deal Industrial Plan

Latham & Watkins LLP on

The Plan aims to “simplify, accelerate and align incentives to preserve the competitiveness and attractiveness of the EU as an investment location for the net-zero industry”. On 1 February 2023, the European Commission...more

Dechert LLP

Upcoming Regulatory Initiatives Impacting Private Fund Managers - September 2022

Dechert LLP on

This latest edition of the regulatory initiatives paper sets out at a high level the core regulatory issues that are likely to impact private fund managers in the coming months, including an overview of the key actions needed...more

K2 Integrity

Navigating the Made in America Landscape: Ensuring Compliance on Infrastructure Projects

K2 Integrity on

Passing the historic $1 trillion Infrastructure Investment and Jobs Act (IIJA) in November 2021, which allocates more than $550 billion in new infrastructure spending, was an early priority of the Biden administration. The...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

Proskauer - Minding Your Business

Revisiting Price Gouging Compliance

With the Biden administration ramping up scrutiny on supply chains and pricing practices, businesses should take a moment to revisit their COVID-19 price gouging compliance.  As we’ve previously highlighted, risk management...more

Jones Day

2022 & Beyond: Continued Challenges in the Automotive Supply Chain

Jones Day on

While our inboxes are flooded on a daily basis with news about how the pandemic has created supply chain and commodities issues, global organizations must think about more than just near-term issues. Although the pandemic...more

Arnall Golden Gregory LLP

It's the Little Things: FDA Issues a Warning Letter for Improper Drug Listing

In a nod to Alice Cooper’s 2000 song, “It’s the Little Things” (or, for literary fans, Robert Frost’s quote, “It’s the little details that are vital; little things make big things bigger”), the Food and Drug Administration’s...more

Foley Hoag LLP

Next Up: Uniform Licensure Standards for Wholesalers and Third-Party Logistics Providers

Foley Hoag LLP on

Key Takeaways: ▪️ FDA has published a proposed rule proposing national licensing standards for prescription drug wholesale distributors and third-party logistics providers as well as standards for third-party accreditation...more

Jones Day

FDA Proposes National Standards for Wholesale Drug Distributors and Third-Party Logistics Providers

Jones Day on

The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more

BakerHostetler

Made in USA, Part Two – How Far Back Do You Have to Look?

BakerHostetler on

Prior to the new year, we blogged about how the Federal Trade Commission’s (Commission) decision to codify its Made in USA (MUSA) guidance into a rule – and the accompanying threat of civil penalties – makes it all the more...more

Jones Day

FERC, NERC Outline Proposed New Reliability Standards Following the February Winter Storm

Jones Day on

The Federal Energy Regulatory Commission's ("FERC") Office of Electric Reliability and Enforcement and the North American Electric Reliability Corporation ("NERC") staff presented a series of findings and preliminary...more

Jones Day

FERC Approves New Cold Weather Reliability Standards

Jones Day on

On August 24, 2021, the Federal Energy Regulatory Commission ("FERC") approved new cold weather electric reliability standards proposed by the North American Electric Reliability Corporation ("NERC"). The standards will apply...more

Hogan Lovells

AI & Algorithms (Part 2): The EU releases its new regulation on artificial intelligence

Hogan Lovells on

On 14 April 2021, the EU Commission’s long-awaited draft proposals for the regulation of artificial intelligence (AI) were leaked. The proposals, which are due to be formally announced on 21 April, set out a bold and...more

Hogan Lovells

FDA issues guidance on conducting remote interactive evaluations during the COVID-19 pandemic

Hogan Lovells on

On April 14, the U.S. Food and Drug Administration (FDA) released the immediately-in-effect guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public...more

Akin Gump Strauss Hauer & Feld LLP

EU-UK Trade and Cooperation Agreement: Initial Impact on Trade Topics

The U.K. and the EU conclude the EU-UK Trade and Cooperation Agreement, which entered into force on December 31, 2020. The Agreement provides guidance on origin rules that must be met for products to benefit from duty-free...more

Hogan Lovells

The European Commission proposes a new Pharmaceutical Strategy for the EU

Hogan Lovells on

On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand....more

WilmerHale

Decoupling From China: Part 1 - Legislation And Funding

WilmerHale on

The COVID-19 pandemic and the serious supply chain vulnerabilities it exposed have led to a seismic shift in U.S. policy and regulation, from stepped-up measures to protect U.S. technology, intellectual property and data from...more

Hogan Lovells

FSMA update: FDA announces pilot program to evaluate third-party food safety standards

Hogan Lovells on

The Food and Drug Administration (FDA) recently announced a pilot program to evaluate whether third-party food safety standards align with the food safety requirements in FDA’s Preventive Controls for Human Food (PCHF) and...more

Hogan Lovells

Doing business in Vietnam: Consumer sector

Hogan Lovells on

Vietnam is one of the most dynamic emerging markets in Southeast Asia. A population of more than 96 million – 70% of whom are under the age of 35 – experiencing rapid and continuing growth in discretionary income has fuelled...more

Hogan Lovells

EMA publishes guidance providing regulatory adaptations for MAHs in the context of COVID-19

Hogan Lovells on

On 10 April 2020, the European Commission, the EMA and the European medicines regulatory network published a notice providing guidance to stakeholders regarding regulatory expectations for medicinal products for human use...more

Hogan Lovells

Supplying medical devices without CE mark in the Netherlands during COVID-19

Hogan Lovells on

In response to the COVID-19 outbreak, the Dutch Healthcare and Youth Inspectorate grants manufacturers and suppliers of medical devices the temporary opportunity to supply medical devices without a CE mark or without having...more

McDermott Will & Emery

COVID-19 – Contingency Planning Checklist for Private Equity Portfolio Companies

McDermott Will & Emery on

Following the wider outbreak of the coronavirus (COVID-19) around the world, radical—and sometimes controversial—actions have been and are further expected to be taken by national, federal and local governments and...more

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