Federal courts will no longer give controlling weight to agency interpretations of ambiguous laws....more
Plaintiffs not initially affected by a regulation may now bring an Administrative Procedure Act ("APA") challenge to the regulation up to six years after they are first affected....more
The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
5/29/2024
/ Abbreviated New Drug Application (ANDA) ,
Canada ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Imports ,
Intellectual Property Protection ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacist ,
Prescription Drugs ,
Supply Chain
The Commodity Futures Trading Commission ("CFTC") published a final rule on April 30, 2024, altering how covered entities fulfill their large trader reporting obligations ("the LTR Rule") and granting CFTC staff significant...more
The Situation: On January 29, 2024, the Office of the Comptroller of the Currency ("OCC") requested comment on a proposed rule updating its bank merger rules and incorporating a policy statement (the "Proposal") on agency...more
2/15/2024
/ Bank Merger Act ,
Banks ,
BSA/AML ,
Community Reinvestment Act ,
Department of Justice (DOJ) ,
Financial Institutions ,
Financial Regulatory Reform ,
Financial Services Industry ,
Global Systemically Important Banks (G-SIBs) ,
Merger Agreements ,
Merger Reviews ,
OCC ,
Policy Statement ,
Proposed Rules
On January 30, 2024, the Securities and Exchange Commission ("SEC") denied a Petition for Rulemaking to amend SEC Rule 202.5(e), known as the SEC's "no-admit/no-deny" rule or, more pejoratively, the "gag rule."...more
In Short -
The Situation: Over the course of 2023, the Financial Stability Oversight Council ("FSOC") took steps that increase the risk of nonbank financial companies and financial activities being designated as...more
A new FCC rule will require comparison shopping websites and lead generators to obtain consumer consent to receive robocalls and robotext messages one seller at a time....more
Two recent developments involving the U.S. Department of Justice's Civil Rights Division ("DOJ") highlight potential risks and opportunities for companies facing immigration-related employment matters....more
11/20/2023
/ Administrative Law Judge (ALJ) ,
Appointments Clause ,
Class Action ,
Constitutional Challenges ,
Department of Justice (DOJ) ,
Employment Policies ,
Foreign Workers ,
H-1B ,
Hiring & Firing ,
Immigration Status Discrimination ,
OCAHO ,
PERM ,
Visas
The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more
10/31/2023
/ Comment Period ,
FDA Approval ,
Food and Drug Act ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform
The D.C. Circuit rebuked the U.S. Securities and Exchange Commission ("SEC") on administrative law grounds but left untouched the test the Agency used to deny proposed bitcoin exchange traded products ("ETP")....more
9/7/2023
/ Arbitrary and Capricious ,
Bitcoin ,
Cryptocurrency ,
Digital Assets ,
Digital Currency ,
Exchange-Traded Products ,
Financial Markets ,
Listing Rules ,
Securities and Exchange Commission (SEC) ,
Securities Regulation ,
Vacated
Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more
In Short -
The Situation: The federal banking agencies approved a proposal that would implement a "gold-plated" U.S. version of the "Basel III endgame."...more
On June 7, the Federal Trade Commission ("FTC" or "Commission") announced a request for public comments ("Request") regarding how it can enhance collaboration efforts with state attorneys general ("AGs") to more effectively...more
This advisory is the latest Commodity Futures Trading Commission ("Commission" or "CFTC") staff action conveying a Commission or staff view that CFTC registrants conducting business in nontraditional ways may need to register...more
In Short -
The Situation: The Financial Stability Oversight Council ("FSOC") recently issued a "notification of proposed interpretive guidance" on updated procedures for designating nonbank financial companies as...more
In Short -
The Situation: The Commodity Futures Trading Commission ("CFTC") staff have issued—and the Commission is now enforcing—a new interpretation of "swap execution facility" that expands the Commodity Exchange Act's...more
In early January 2023, the Federal Trade Commission ("FTC") proposed an unprecedented rule banning most employer/employee non-compete clauses. As detailed below, the rule is not likely to take effect for at least eight...more
1/13/2023
/ Comment Period ,
Contract Terms ,
Employment Contract ,
Federal Trade Commission (FTC) ,
FTC Act ,
Non-Compete Agreements ,
Proposed Rules ,
Public Comment ,
Restrictive Covenants ,
Section 5 ,
Unfair Competition
In Short -
The Situation: The National Labor Relations Board ("NLRB" or "Board") recently issued a Notice of Proposed Rulemaking to articulate the standard for determining joint-employer relationships under the National...more
Court orders agency to provide better explanation for List 3 and List 4A by June 30, 2022.
On April 1, 2022, a three-judge panel of the U.S. Court of International Trade issued an opinion in a test case for more than...more
In 2018, the FCC deregulated broadband internet access service, repealed its 2015 net neutrality rules, and specified that these actions were intended to preempt state net neutrality laws. On appeal, the D.C. Circuit upheld...more
2/7/2022
/ Biden Administration ,
Broadband ,
FCC ,
Infrastructure ,
Internet ,
Internet Service Providers (ISPs) ,
Net Neutrality ,
Open Internet Rules ,
Preemption ,
Public Utility ,
Telecommunications
The Board Diversity Proposal generally requires each Nasdaq-listed company "to have, or explain why it does not have, at least two members of its board of directors who are Diverse," defined as at least one director who...more
8/16/2021
/ Board of Directors ,
Corporate Governance ,
Disclosure Requirements ,
Diversity and Inclusion Standards (D&I) ,
LGBTQ ,
Listing Standards ,
Minorities ,
Nasdaq ,
Publicly-Traded Companies ,
Regulatory Agenda ,
Rulemaking Process ,
Securities and Exchange Commission (SEC) ,
Woman Board Members
Overview As previously discussed here, pursuant to Executive Order 14026 signed by President Biden on April 27, 2021, the Department of Labor ("DOL" or "Department") recently published a notice of proposed rulemaking titled...more
The Road Toward Better Infrastructure -
On August 1, 2021, the Senate proposed the Infrastructure Investment and Jobs Act, a $1.2 trillion infrastructure bill including $550 billion in new spending to improve the country's...more
8/3/2021
/ Airports ,
Biden Administration ,
Bridges ,
Broadband ,
Electric Vehicles ,
Federal Funding ,
Infrastructure ,
Legislative Agendas ,
Power Infrastructure ,
Proposed Legislation ,
Public Transportation ,
Roads ,
Water
Executive Order directs whole-of-government approach and broad regulatory effort.
On May 20, 2021, President Biden issued an Executive Order ("Order") directing agencies to analyze and mitigate "climate-related financial...more