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Administrative Agency Civil Remedies

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.
Latham & Watkins LLP

China Clarifies Privacy and Data Security Requirements in Network Data Security Management Regulations

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The Regulations, which took effect on January 1, 2025, reiterate and clarify existing requirements and introduce new ones on privacy and network data security....more

K&L Gates LLP

Complying With the New "Open Banking" Regime: Primer and Fact Sheet

K&L Gates LLP on

The Consumer Financial Protection Bureau (CFPB) finalized its “open banking” rule in late 2024. As required by Section 1033 of the Consumer Financial Protection Act, the CFPB promulgated the rule to require certain financial...more

A&O Shearman

EU final report on updated guidelines on stress test scenarios under Money Market Funds Regulation

A&O Shearman on

The European Securities and Markets Authority has published its final report on guidelines on stress test scenarios under the Money Market Funds Regulation. The MMF Regulation requires ESMA to annually update the guidelines,...more

BakerHostetler

Proposed TDHCA Rule to Require Local Approval for Property Tax Exemptions on Certain Properties

BakerHostetler on

At its Dec. 12, 2024 board meeting, the TDHCA included on its board agenda a proposed change to Section 10.406 of the Texas Administrative Code (Section 10.406). Under the proposed change, prior to an ownership transfer of a...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

H-2B Cap Reached for Additional Returning Workers for First Half of Fiscal Year 2025

U.S. Citizenship and Immigration Services (USCIS) has announced that as of January 7, 2025, the additional returning H-2B worker allotment of 20,716 visas for the first half of fiscal year (FY) 2025 (October 1, 2024, to March...more

Bradley Arant Boult Cummings LLP

New Year, New Leave Laws – Understanding State Leave Law Updates Effective January 1, 2025

When did you last look at your employee leave policies? As the calendar turns to a new year, new changes often arrive, and 2025 is no exception. Employers should take note of the recent updates to state leave laws that went...more

McDonnell Boehnen Hulbert & Berghoff LLP

2024 Report on Notorious Markets

The Office of the U.S. Trade Representative (USTR) issued its "2024 Review of Notorious Markets for Counterfeiting and Piracy" on January 8th, directed to "prominent and illustrative examples of online and physical markets...more

Latham & Watkins LLP

FDA Finalizes Guidance on Communications of Scientific Information on Unapproved Uses

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The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more

Jackson Lewis P.C.

Hong Kong Residents Protected By New Deferred Enforced Departure Directive

Jackson Lewis P.C. on

President Joe Biden is extending Deferred Enforced Departure (DED) for 24 months through Feb. 5, 2027, for any Hong Kong resident (regardless of country of birth) currently living in the United States....more

DLA Piper

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

DLA Piper on

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

PilieroMazza PLLC

SBA Update: New Rule Makes Major Changes to Eligibility and Certification Requirements for HUBZone Program

PilieroMazza PLLC on

As PilieroMazza noted on December 17, 2024, the Small Business Administration (SBA or the Agency) published a final rule that will make changes to its regulations for the Historically Underutilized Business Zone (HUBZone)...more

Venable LLP

AI On the Prize: Decoding FDA's Latest Guidance

Venable LLP on

Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more

Estlund Law, P.A.

INTERPOL’S CCF: Less Is More For Red Notice Removal Requests

Estlund Law, P.A. on

Late last year, after growing increasingly frustrated with the CCF’s uncharacteristically delayed responses to both access requests and removal requests, we inquired directly to the CCF as to the Commission’s seeming lack of...more

McDermott Will & Emery

Bit Swap: Motivation to Modify Prior Art Needn’t Be Inventor’s Motivation

McDermott Will & Emery on

Addressing the issue of obviousness, the US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board decision, finding that the challenged patent claims were obvious because a person of ordinary skill...more

McDermott Will & Emery

Pink Is Not the New Black: See Functionality Doctrine

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed a Trademark Trial & Appeal Board decision canceling trademarks for the color pink for ceramic hip components, stating that substantial evidence supported the Board’s...more

Womble Bond Dickinson

FDA Sets Action Levels For Lead

Womble Bond Dickinson on

A year ago, the FDA issued draft guidance for lead levels in baby foods. In the year since the FDA issued its draft guidance for lead levels in baby food, two states, California and Maryland, have adopted laws which require...more

Troutman Pepper Locke

Cannabis Rescheduling: ALJ Cancels Upcoming Hearings on Proposed Rulemaking

Troutman Pepper Locke on

Hearings on the merits of the Drug Enforcement Agency’s (DEA) proposed cannabis rescheduling, initially set to begin this month, have been cancelled. The preliminary hearing period has been littered with accusations that the...more

Ropes & Gray LLP

FDA and OHRP Issue Draft Guidance on Including Biopsies in Clinical Trials

Ropes & Gray LLP on

On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more

Ballard Spahr LLP

CFPB proposes rule to ban consumer contract terms bureau says limit ‘fundamental freedom’

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The CFPB has published a proposed rule that would ban companies from using contract clauses that the bureau said limit fundamental freedom, including those that waive a consumer’s legal rights and fine print that suppresses...more

Ballard Spahr LLP

FHWA to Eliminate Buy America Manufactured Products Waiver for Federally-Assisted Highway Projects

Ballard Spahr LLP on

On January 14, 2025, the U.S. Department of Transportation (USDOT) Federal Highway Administration (FHWA) issued a final rule discontinuing its longstanding Buy America waiver for manufactured products used in...more

Bradley Arant Boult Cummings LLP

Practical Considerations for Navigating Tariff Risk on Construction Projects

As the second Trump administration begins next week, developers, contractors, subcontractors and suppliers are evaluating the extent of the construction industry’s international ties – and contractual exposure to potential...more

Ballard Spahr LLP

CFPB re-establishes regulatory sandbox, no-action letter programs

Ballard Spahr LLP on

In an effort to foster innovation in financial services, the CFPB is reinstituting its programs that allow companies to obtain regulatory safe harbors through no-action letters and sandboxes to test new products and services....more

Troutman Pepper Locke

CFPB Issues a Roadmap for States Days Before Trump Takes Office

Troutman Pepper Locke on

As the Consumer Financial Protection Bureau (CFPB or Bureau) anticipates a shift in its leadership with the incoming administration of President Trump, the Bureau has released a report titled “Strengthening State-Level...more

McDermott+

Outlook for Medicare Advantage Under the Trump Administration

McDermott+ on

Medicare Advantage (MA), the private insurance option under Medicare, is one of many policy areas that will garner great attention in 2025 and beyond under the incoming Trump Administration. We recently released our 2025...more

Shipman & Goodwin LLP

OCR Confirms That the 2024 Title IX Regulations Are Vacated

Shipman & Goodwin LLP on

On January 9, 2025, a federal district court in Kentucky ruled that the 2024 Title IX Regulations “are invalid and must be set aside.” Despite some ambiguity in the text of the decision, we concluded that the ruling likely...more

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