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Disclosure Requirements Transparency Regulatory Oversight

Latham & Watkins LLP

FDA Publishes Complete Response Letters for Unapproved Drug Applications

Latham & Watkins LLP on

On September 4, 2025, the US Food and Drug Administration (FDA or the Agency) announced that it released a second batch of complete response letters (CRLs) — which explain the Agency’s determination for refusing to approve a...more

Hogan Lovells

FDA releasing Complete Response Letters for drugs and biologics that have not yet been approved

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) is now releasing complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications. ...more

Herbert Smith Freehills Kramer

The NSTA’s New Disclosure Policy

On 31 July 2025, the North Sea Transition Authority (NSTA) confirmed its new approach to regulatory transparency by announcing its intention to publicly name companies subject to ongoing investigations and those who fail to...more

Holland & Knight LLP

Proyecto de Decreto para la implementación del Acuerdo de Escazú en Colombia

Holland & Knight LLP on

El Ministerio de Ambiente y Desarrollo Sostenible de Colombia publicó para comentarios un Proyecto de Decreto "Por el cual se crea la Comisión Intersectorial para la implementación del Acuerdo Regional sobre el Acceso a la...more

Lathrop GPM

Trends in State-Based AI Governance Regulations

Lathrop GPM on

Texas recently became the latest state to enter the conversation about AI governance regulation with House Bill 149, the Texas Responsible Artificial Intelligence Governance Act (TRAIGA) in June. As states continue to grapple...more

Mayer Brown

EU AI Act News: Rules on General-Purpose AI Start Applying, Guidelines and Template for Summary of Training Data Finalized

Mayer Brown on

Obligations relating to general-purpose artificial intelligence (“GPAI”) models under the EU AI Act enter into force on 2 August 2025. Ahead of this deadline, the European Commission (the “Commission”) has published a suite...more

Orrick, Herrington & Sutcliffe LLP

Massachusetts Attorney General introduces new regs against “junk fees”

On March 3, the Massachusetts Attorney General (AG) announced new regulations to combat so-called “junk fees” by requiring businesses to disclose total product costs upfront and simplify cancellation processes for trial...more

Cooley LLP

[Webinar] AI Talks: AI + Regulatory - November 13th, 12:00 pm - 1:00 pm EDT

Cooley LLP on

This session of Cooley’s AI Talks will cover ways to navigate the US, European Union, and UK regulatory and legislative risks of AI, including strategies for engaging with policymaking bodies and analyzing the business...more

Pillsbury - Global Sourcing Practice

California Legislature Passes Generative AI Training Data Transparency Bill

The California legislature recently passed Assembly Bill 2013 (AB 2013) on August 27, 2024, a measure aimed at enhancing transparency in AI training and development. If signed into law by Governor Gavin Newsom, developers of...more

Goldberg Segalla

New SEC Climate Disclosure Mandate Faces Pushback

Goldberg Segalla on

The U.S. Securities and Exchange Commission last week approved the implementation of standardized climate disclosure rules (posted here) for publicly traded companies and in public offerings. No longer can companies simply...more

K&L Gates LLP

Brussels Regulatory Brief: February 2024

K&L Gates LLP on

Antitrust and Competition - The European Commission Carried Out Unannounced Inspections in the Tires Sector - On 30 January 2024, the Commission conducted dawn raids at the premises of several companies active in the tires...more

Cadwalader, Wickersham & Taft LLP

European Commission Adopts Disclosure Templates for EU Securitisation Reporting

The Securitisation Regulation applies to securitisations, the securities of which are issued (or where no securities are issued, the securitisation positions of which are created) on or after 1 January 2019....more

Cadwalader, Wickersham & Taft LLP

ESMA’s Final Draft Disclosure Technical Standards

On 22 August 2018, the European Securities and Markets Authority (“ESMA”) published its Final Report on the technical standards on disclosure requirements under the EU Securitisation Regulation (the “Final Report”)....more

Hogan Lovells

U.S. Senate passes bill requiring prescription drug ads to include prices

Hogan Lovells on

On Thursday, the U.S. Senate passed (85-7) the fiscal year 2019 minibus appropriations bill (H.R.6157) that would fund the Departments of Labor, Health and Human Services (HHS), and Education, attaching to it a large...more

Jones Day

The European Securitisation Regulation: The Countdown has Begun....

Jones Day on

Draft Technical Standards Published for Consultation by the European Supervisory Authorities—An Update and Overview - Regulation (EU) 2017/2402, which is known as the "Securitisation Regulation" and lays down a general...more

Seyfarth Shaw LLP

A Modern Slavery Act For Australia

Seyfarth Shaw LLP on

Over 40 million people around the world are trapped in conditions of modern slavery, according to estimates from the Walk Free Foundation and International Labour Organization, including an estimated 4300 victims “hidden in...more

Hogan Lovells

UK Modern Slavery Act – are tougher disclosure requirements on their way?

Hogan Lovells on

Disclosure requirements under the UK Modern Slavery Act 2015 (‘MSA’) have pushed many businesses operating in the UK to gather and interrogate information about human rights risks across their operations and supply chains –...more

Jones Day

Italy Enacts New Anti-Raider Rules to Protect Strategic Assets

Jones Day on

The Situation: Recent foreign investments in Italian blue chips led the Italian government to intervene to protect strategic assets. The Result: Decree 148/2017 introduced new disclosure requirements regarding...more

Hogan Lovells

Italy improves transparency and extends its "golden powers" to protect new (corporate) treasures

Hogan Lovells on

On October 16, 2017 the Italian government adopted Law Decree no. 148/2017 (the "Decree") containing, inter alia, new measures aimed at improving the transparency of Italy's regulated markets and extending the Italian...more

Burr & Forman

Can There Be Too Much Disclosure?

Burr & Forman on

In an effort to provide transparency, the Dodd-Frank Act has previously formed an Investor Advisory Committee to assist the SEC on various issues including regulatory priorities, the regulation of securities products, trading...more

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