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Regulatory Authority Enforcement Actions Regulatory Requirements

Baker Botts L.L.P.

Referrals under Article 22 EUMR — Levels of information required to kick off the statutory deadline for referral by an NCA

Baker Botts L.L.P. on

On 2 July 2025, the Court of Justice of the European Union (General Court) clarified that simply "informing" the authorities of a proposed concentration isn’t enough to kick off the 15-working-days time limit under which a...more

Polsinelli

Federal Reserve Board Enforcement Action Raises Concerns as to Reach of Regulators’ Jurisdiction

Polsinelli on

Key Takeaways - The Federal Reserve Board issued a removal and prohibition order against a former bank employee based on alleged misconduct unrelated to her role at the bank, raising concerns about the scope of regulatory...more

Morrison & Foerster LLP

CPSC Issues Weekly Record Level of Product Safety Notices

As noted in our recent client alert, the U.S. Consumer Product Safety Commission (CPSC) continues to aggressively pursue enforcement actions for violations of the Consumer Product Safety Act (CPSA) against foreign...more

Stikeman Elliott LLP

Recent Biometrics Decisions from Québec’s Data Protection Authority: Five Key Takeaways

Stikeman Elliott LLP on

Two recent decisions by Québec’s data protection authority, the Commission d’accès à l’information (the “CAI”), should serve as cautionary tales for any business contemplating the deployment of biometric information...more

Baker Botts L.L.P.

Right to Erasure in the Spotlight as EU Data Protection Board Launches 2025 Coordinated Action

Baker Botts L.L.P. on

The European Data Protection Board (EDPB), the independent EU body responsible for ensuring the consistent application of the EU General Data Protection Regulation (GDPR) across all EU member states, has kicked off its...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more

Nelson Mullins Riley & Scarborough LLP

New Rule on SEC Delegation of Authority to Director

On March 10, 2025, the U.S. Securities and Exchange Commission (SEC) announced its final rule rescinding the delegation of authority that had allowed the SEC’s Director of the Division of Enforcement’s (“Director”) to “issue...more

Harris Beach Murtha PLLC

Supreme Court Ruling on EPA Water Permits

The United States Supreme Court has issued a significant ruling in the case of San Francisco v. EPA, directing the Environmental Protection Agency (EPA) to retool its wastewater permitting process under the Clean Water Act....more

Morrison & Foerster LLP

Take it to the Top: The SEC Rescinds Its Delegation to the Enforcement Division to Issue Formal Orders

To issue a subpoena for documents or testimony, Enforcement staff must first obtain a formal order. A formal order authorizes SEC staff “to administer oaths and affirmations, subpoena witnesses, compel their attendance, take...more

Hogan Lovells

State Licensing Spotlight – Prescription Medical Device Manufacturers & Distributors: Enforcement and penalties for operating...

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The regulatory environment for prescription medical device manufacturers and distributors has become increasingly stringent as state-based agencies work to ensure public health and safety. Operating without a required license...more

Ballard Spahr LLP

SEC Curtails Enforcement Leadership’s Investigation and Subpoena Power, Signals Greater Commissioner Oversight Over Enforcement

Ballard Spahr LLP on

On Monday, March 10, 2025, the SEC announced a new final rule revoking the Director of Enforcement’s previous authority to issue formal orders, which have the effect of officially initiating investigations and permitting...more

DLA Piper

Supreme Court Limits EPA's Permitting Authority Under the Clean Water Act

DLA Piper on

The Supreme Court recently ruled that the Clean Water Act (CWA) does not authorize the Environmental Protection Agency (EPA) to impose “generic” or “end-result” prohibitions in National Pollutant Discharge Elimination System...more

Bergeson & Campbell, P.C.

ECHA Updates Annual Evaluation Statistics and Recommendations to Registrants on Improving Dossiers

The European Chemicals Agency (ECHA) announced on February 26, 2025, that it has updated its annual statistics on evaluation progress. According to ECHA, between 2009 and 2024, it checked the compliance of 15,500...more

Allen Matkins

California Environmental Law & Policy Update 3.7.25

Allen Matkins on

On Tuesday, in a 5-4 opinion authored by Justice Samuel Alioto, the U.S. Supreme Court issued a pivotal ruling that the Clean Water Act (CWA) provisions authorizing the U.S. Environmental Protection Agency (EPA) to impose...more

Goldberg Segalla

Supreme Court Requires EPA to Set Specific Targets in Water Permits

Goldberg Segalla on

The U.S. Supreme Court on Tuesday, in San Francisco v. EPA, held in a 5-4 decision that the EPA cannot enforce requirements in wastewater permits that “do not spell out what a permittee must do or refrain from doing.” San...more

Stinson LLP

Supreme Court Rules for Permit Holders on Age-Old CWA Dispute

Stinson LLP on

In a 5-4 ruling on March 4, the U.S. Supreme Court held that the Environmental Protection Agency (EPA) lacks authority to impose Clean Water Act (CWA) conditions in National Pollutant Discharge Elimination System (NPDES)...more

Barnea Jaffa Lande & Co.

Israel Steps Up Enforcement on Retail Price Marking Violations

The Ministry of the Economy’s wide-scale enforcement campaign launched last weekend in branches of supermarket chains throughout the country, found violations of the obligation to mark prices in all of the branches that were...more

Morrison & Foerster LLP

CPSC Warns Consumers to Stop Using Sport Nets

On December 19, 2024, the Consumer Product Safety Commission (CPSC) unilaterally issued a warning to consumers to stop using Sport Nets 4’ x 8’ portable soccer goals. According to CPSC, an exposed metal tip at the top of the...more

Mayer Brown

Brazil: Federal Decree Regulates FUNAI's Enforcement Powers

Mayer Brown on

AT A GLANCE - Federal Decree No. 12,373/2025, published on February 3, 2025, reinforces FUNAI’s regulatory authority over indigenous lands and restricted areas by outlining offenses such as unauthorized entry by...more

Gardner Law

State Licensing Requirements: Are You Prepared?

Gardner Law on

Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not the final step. Before selling your products in most states, you must navigate state licensing...more

DLA Piper

Romania - VAT: Extension of the Applicability of RO e-Invoicing System to B2C Transactions - Monthly Indirect Tax Alert – January...

DLA Piper on

1 January 2025 marked the entry into force of the obligation for Romanian established taxpayers that carry out taxable operations in Romania to report in the Romanian invoicing System the invoices issued in B2C transactions....more

Goodell, DeVries, Leech & Dann, LLP

Understanding CMS “Immediate Jeopardy” Investigations in Healthcare Facilities

When it comes to ensuring patient safety, healthcare facilities operate under a complex regulatory framework, including oversight from the Centers for Medicare & Medicaid Services (CMS). One of the more intense processes CMS...more

Cooley LLP

Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings

Cooley LLP on

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter from the US Food and Drug Administration (FDA) on the heels of a routine...more

Davies Ward Phillips & Vineberg LLP

Changes to Québec’s Consumer Protection Regime: Monetary Administrative Penalties and Increased Penal Fines

Significant changes to the Québec consumer protection regime came into effect earlier this year. The president of the Office de la protection du consommateur (OPC), Québec’s consumer protection regulator, can now impose...more

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