News & Analysis as of

New Guidance Regulatory Requirements Risk Assessment

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Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more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

ArentFox Schiff on

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

Alston & Bird on

Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing....more

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

Health Care Compliance Association (HCCA)

[Event] Regional Compliance & Ethics Conference - February 22nd - 23rd, Anchorage, AK

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - February 22nd - 23rd, Anchorage, AK

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

NAVEX

[Virtual Conference] NAVEX Next: Beyond the Moment - October 22nd, 8:00 am - 2:00 pm PDT

NAVEX on

Register for NAVEX Next, our annual risk and compliance virtual conference. Formerly the Ethics & Compliance Virtual Conference (ECVC), the new name recognizes that we must be forward-looking as we face an increasingly...more

NAVEX

Finding Your Footing in a Sea of Regulations and Guidance

NAVEX on

The compliance officer woke up in a cold sweat. In his nightmare, once again the regulator had spoken. Only this time, it was a marauding hoard of regulators spouting guidance, regulations and legislation. The acronyms came...more

Skadden, Arps, Slate, Meagher & Flom LLP

SEC Staff Issues Disclosure Guidance on International Intellectual Property and Technology Risks

In December 2019, the Division of Corporation Finance (Staff) of the U.S. Securities and Exchange Commission (SEC) published new "CF Disclosure Guidance: Topic No. 8" (Guidance) regarding disclosure obligations companies...more

Vedder Price

Investment Services Regulatory Update - February 2018

Vedder Price on

New Rules, Proposed Rules, Guidance and Alerts – SEC STAFF GUIDANCE AND ALERTS - SEC Staff Issues Guidance on Cryptocurrency-related Holdings - On January 18, 2018, the staff of the SEC’s Division of Investment...more

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