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Regulatory Oversight Compliance

Gardner Law

Staying Prepared Amid FDA Changes

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Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Conyers

Understanding Outsourcing Obligations for Cayman Islands Funds

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It has been two years since the Cayman Islands Monetary Authority (CIMA) introduced its Rule on Corporate Governance for Regulated Entities (the “Corporate Governance Rule”), and a year and a half since it came into force....more

Morrison & Foerster LLP

Proactivity in Product Safety: Best Practices for Compliance

Consumer product companies are facing unprecedented scrutiny as the Consumer Product Safety Commission (CPSC) intensifies its regulatory oversight. With heightened civil penalties, increased monitoring of e-commerce...more

Alston & Bird

5 Things to Think About When Using AI

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What Happened? As the Trump Administration’s deregulatory, pro-innovation approach to emerging technology moves forward, the use of artificial intelligence has taken center stage, and it is clear that the Administration...more

Mayer Brown

Brasília em Pauta – Edição Nº 201

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Prezados e prezadas, O “Brasília em Pauta” é um boletim semanal preparado pela equipe de Contencioso de Brasília, contendo os principais casos a serem julgados pelo Supremo Tribunal Federal (STF), Superior Tribunal de...more

Health Care Compliance Association (HCCA)

‘I Really Wanted to Stay’: Amid Success, Regrets, OHRP’s Kaneshiro Hopes Agency Will Be Rebuilt

When Jerry Menikoff retired at the end of 2022 after leading the HHS Office for Human Research Protections (OHRP) for 14 years, he left behind an agency limping along with 20 employees, less than half of what it needed. For...more

Ropes & Gray LLP

Five Takeaways From the EU Commission’s AI Literacy Q&As

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Earlier this month, the European Commission released AI Literacy – Questions & Answers. The Q&As are a useful primer — both for organisations at the start of their literacy journey and those that, having taken steps to...more

Health Care Compliance Association (HCCA)

And Then There Were Nine: Disappearing OHRP To Join Enforcement Agency; NIH Cuts Outlined

When it comes to changes roiling the federally supported research landscape, April offered no letup from the first three months of the year; if anything, the pace and magnitude increased. In one instance, an agency—the HHS...more

White & Case LLP

AI Watch: Global regulatory tracker - OECD

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The OECD's AI recommendations encourage Member States to uphold principles of trustworthy AI. Status of the AI Regulations - The Adherents have agreed to promote, implement, and adhere to the Recommendation. The Principles...more

Lippes Mathias LLP

The Future of Monitorships

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In 2008, then-President Barack Obama famously said, “Elections have consequences.” Seventeen years later that statement is still true. A change in administration at either the federal or state government level ushers in new...more

Mayer Brown

New Federal Decree Regulates Renovabio Penalties

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On April 17, Federal Decree No. 12,437/2025 (the “Decree”) was published, regulating recent amendments to the National Biofuels Policy (Renovabio) introduced by Law No. 15,082/2024. The Decree aims to strengthen oversight...more

Mayer Brown

Brasília em Pauta – Edição Nº 198

Mayer Brown on

Prezados e prezadas, O “Brasília em Pauta” é um boletim semanal preparado pela equipe de Contencioso de Brasília, contendo os principais casos a serem julgados pelo Supremo Tribunal Federal (STF), Superior Tribunal de...more

Troutman Pepper Locke

AI Legislation: The Statewide Spotlight - Regulatory Oversight Podcast

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Join us for a special crossover episode of The Consumer Finance Podcast and Regulatory Oversight, where Chris Willis, Kim Phan, and Gene Fishel delve into the evolving world of state AI legislation. As AI becomes a pivotal...more

HaystackID

Legal Data Intelligence Celebrates First Anniversary with Expanded Framework and New Use Cases

HaystackID on

The Legal Data Intelligence (LDI) initiative has reached a significant milestone as it marks its first year of operation. Since its May 2024 launch, it has demonstrated remarkable growth and evolution. What began as an...more

Davis Wright Tremaine LLP

CFTC Divisions Issue Staff Advisory on Referrals to Division of Enforcement

On April 17, 2025, the Market Participants Division, the Division of Clearing and Risk, and the Division of Market Oversight (collectively, the "Operating Divisions") of the CFTC, along with the Division of Enforcement...more

King & Spalding

Trump Administration Early Executive Orders Signal Shift in AI Policy

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Since returning to office, President Trump quickly issued two executive orders that mark a significant shift in the federal government’s approach to artificial intelligence regulation and oversight (“Trump AI EOs”). These...more

A&O Shearman

SRB consultation on expectations on valuation capabilities

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The Single Resolution Board (SRB) has published a press release confirming it had launched a public consultation on its expectations on valuation capabilities (dated 1 April). The consultation forms part of the Single...more

ArentFox Schiff

FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews

ArentFox Schiff on

In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications...more

A&O Shearman

RTS on criteria for the composition of joint examination teams under EU DORA published in OJ

A&O Shearman on

Commission Delegated Regulation 2025/420 has been published in the Official Journal of the EU. This Delegated Regulation supplements Regulation 2022/2554 on digital operational resilience for the financial sector (DORA)...more

Walkers

The BMA invites proposals to test Embedded Supervision in DeFi

Walkers on

The Bermuda Monetary Authority ("BMA") has issued an invite for proposals from voluntary participants to take part in a pilot project aimed at testing Embedded Supervision practices within the context of DeFi. Embedded...more

Flaster Greenberg PC

SEC Offers Updated Guidance for Rule 506(c) Private Placements

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On March 12, 2025, the SEC published a No-Action Letter clarifying accredited investor verification requirements under Rule 506(c)....more

Rivkin Radler LLP

Quality of Care Considerations in OIG’s Nursing Facility Compliance Guidance

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In November 2024, the U.S. Department of Health and Human Services’ Office of the Inspector General (“OIG”) published the long-awaited Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (“Nursing...more

Chambliss, Bahner & Stophel, P.C.

How To Get a Disabled Parking Permit

Disabled parking permits enable individuals with mobility issues to access businesses and public spaces more easily. Different types of disabled parking permits include permanent and temporary placards, license plates,...more

Cadwalader, Wickersham & Taft LLP

Regulation in Flux, March 2025 - CFTC Staff Withdraws Advisory on Swap Execution Facility Registration Requirement

On March 13, 2025, the Commodities Futures Trading Commission (“CFTC”) issued Letter 25-05, withdrawing controversial and much-criticized Staff Letter 21-19 (“SEF Registration Advisory”), which was issued September 29, 2021...more

Mayer Brown Free Writings + Perspectives

The SEC’s Staff of the Division of Corporation Finance Clarifies Its Views on Crypto Mining

On March 20, 2025, the SEC’s Staff of the Division of Corporation Finance (the “Division”) issued a statement providing its views that crypto mining activities (as defined in its statement) do not involve the offer and sale...more

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