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Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

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In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

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The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

Stoel Rives LLP

DOJ Antitrust Division’s Updated Guidance On Evaluating Corporate Compliance Programs Includes New Focus On AI And Electronic...

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The U.S. Department of Justice Antitrust Division has updated its Evaluation of Corporate Compliance Programs in Criminal Antitrust Investigations (the “Guidance”). This Guidance updates the 2019 guidance to federal antitrust...more

MG+M The Law Firm

EPA Extends TSCA Section 8(d) Reporting Deadlines for Chemical Data Submissions

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The US Environmental Protection Agency (EPA) has announced plans to extend the reporting deadlines for a rule under Section 8(d) of the Toxic Substances Control Act (TSCA). This rule mandates that manufacturers and importers...more

Bressler, Amery & Ross, P.C.

NY Department of Financial Services Issues Guidance to its Regulated Industry As a Result of the Ongoing Global Conflict

The New York State Department of Financial Services (the “Department”) has issued guidance (“Guidance”) to all individuals and entities regulated by the Department (“Regulated Entities”) to underscore the importance of...more

BakerHostetler

DSIR Deeper Dive: Artificial Intelligence - Banner Years (and Counting) for AI Guidance and Regulation

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The period of 2024-2025 was significant for AI law, regulation, and guidance, beginning in early February 2024, and the news told the tale...more

Constangy, Brooks, Smith & Prophete, LLP

Warning: Cyber criminals are coming for your client’s retirement information

As cyberattacks and cybercriminals are becoming increasingly sophisticated, safeguarding employee benefit plans, including health and welfare plans, is crucial. The Employee Benefits Security Administration of the U.S....more

Hogan Lovells

NIST finalizes cybersecurity incident response framework profile aligned with CSF 2.0

Hogan Lovells on

On April 3, NIST published practical incident response guidance aligned with its CSF 2.0 framework. The guidance outlines best practices in security incident preparation and response for organizations mapped across each of...more

Morgan Lewis

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

Morgan Lewis on

On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

McDermott Will & Emery on

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

ArentFox Schiff

FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics

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In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more

Alston & Bird

Manufacturers Take Note: FDA Clarifies In-Process Sampling Under Section 211.110

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Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing....more

Fisher Phillips

Top 6 Employer Takeaways From New EEOC Wearable Tech Guidance

Fisher Phillips on

Wearable technologies are becoming increasingly common in the workplace, but a new guidance document from the Equal Employment Opportunity Commission (EEOC) has made it clear that employers need to tread carefully. From smart...more

A&O Shearman

Practical tips for large organisations to ensure reasonable procedures to prevent fraud are in place

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We distil key practical takeaways from the UK Government’s official guidance on the corporate criminal offence of failure to prevent fraud (the Guidance). Businesses and compliance teams will be working to review and...more

A&O Shearman

New UK guidance on failure to prevent fraud - what does it tell businesses about how the offence will apply?

A&O Shearman on

The UK Government has finally published its official guidance on the corporate criminal offence of failure to prevent fraud (the Guidance). The offence will come into force on 1 September 2025. By then, businesses that fall...more

WilmerHale

UK Government Publishes Guidance on New Failure to Prevent Fraud Offence

WilmerHale on

On 6 November 2024, the UK Government published the much-anticipated guidance on the new corporate offence of failure to prevent fraud (the “Guidance”). The failure to prevent fraud offence forms part of a huge shift in the...more

Parker Poe Adams & Bernstein LLP

What DOJ's Latest Guidance on Artificial Intelligence Corporate Compliance Means for Businesses

The U.S. Department of Justice (DOJ) recently updated its Evaluation of Corporate Compliance Programs (ECCP), which prosecutors consider when investigating, charging, and negotiating plea or other agreements with...more

Moore & Van Allen PLLC

OCC Issues Guidance Reminding Banks of Risks Associated with Refinancing Commercial Loans

Moore & Van Allen PLLC on

With the amount of commercial real estate loans scheduled for maturity over the next several years expected to increase significantly, there is accompanying heightened risk that some borrowers may be unable to replace their...more

Goodwin

NYDFS Publishes Guidance on AI-Related Cybersecurity Risks

Goodwin on

On October 16, 2024, the New York State Department of Financial Services (NYDFS or the “Department”) published an industry letter (the “Guidance”) regarding the increased reliance on artificial intelligence (AI) and the...more

K2 Integrity

First Ever Targeted Guidance On Financial Institutions’ Compliance With Export Administration Regulations

K2 Integrity on

On 9 October 2024, the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) published its first ever unilateral guidance specifically addressed to financial institutions (FIs). The Guidance to Financial...more

Harris Beach Murtha PLLC

NY Department of Financial Services Issues AI Cybersecurity Guidance

Harris Beach Murtha PLLC on

The New York Department of Financial Services (DFS) has issued guidance, in the form of an industry letter, on addressing cybersecurity risks arising from artificial intelligence (AI) under its cybersecurity regulation, 23...more

Bradley Arant Boult Cummings LLP

DOJ Expects Corporate Compliance Programs to Keep Pace with Artificial Intelligence

Newly Updated Evaluation of Corporate Compliance Programs (ECCP) Addresses AI for the First Time - On September 23, 2024, the U.S. Department of Justice (DOJ) revised its Evaluation of Corporate Compliance Programs (ECCP)....more

Jones Day

DOJ Updates Corporate Compliance Program Guidance With a Focus on AI and Emerging Technologies

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The Situation: In September 2024, the U.S. Department of Justice ("DOJ" or "Department") announced updates to its Evaluation of Corporate Compliance Programs guidance covering three primary areas: (1) the risks of artificial...more

Epiq

Webinar Takeaways: Managing Antitrust Risk When Using Artificial Intelligence — a US Perspective

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Artificial Intelligence (AI) can help corporations create operational efficiencies, enhance customer experiences, optimize business strategies, significantly reduce costs, and increase profitability. However, using AI tools...more

BCLP

Sexual Harassment - The Preventative Duty

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After a slightly extended summer break, we return with a summary of the new sexual harassment rules due to come into force in just over two weeks....more

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