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Hogan Lovells

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

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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complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications.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

A&O Shearman

EC Publishes Draft Acts Revising REMIT IR and Introducing New Rules for IIPs and RRMS

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The European Commission (EC) has published two draft regulations which aim to modernise and reinforce the transparency and integrity of the EU's wholesale energy markets under Regulation (EU) No 1227/2011 on Wholesale Energy...more

Burr & Forman

U.S. AI Laws and What They Mean for Your Business

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It seems like everywhere you look, artificial intelligence (“AI”) is being talked about. It no longer carries that stigma that it is just for tech giants. Businesses across industries are integrating AI into their operations....more

Troutman Pepper Locke

Colorado AI Act Amendment Bills for Special Session Released

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Starting August 21, Colorado lawmakers will consider four bills that significantly amend the Colorado AI Act....more

Loeb & Loeb LLP

Will There Be a New York Law Requiring Disclosure of AI Use in Advertising?

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New York’s proposed Synthetic Performer Disclosure Bill (A.8887-B/S.8420-A) is positioned to become the first law in the United States requiring clear disclosures in advertisements that use AI-generated or digitally altered...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU’s General-Purpose AI Obligations Are Now in Force, With New Guidance

- What is new: The EU AI Act’s obligations on general-purpose AI providers have now come into force alongside the publication of guidance, a code of practice and a disclosure template that flesh out GPAI model providers’...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

Fox Rothschild LLP

When It Comes to AI, Transparency Is Key

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If you use a bot powered by artificial intelligence to interact with consumers, you need to disclose it. A new law in Maine that goes into effect in September 2025 requires businesses to notify consumers in a clear and...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

Constangy, Brooks, Smith & Prophete, LLP

Appellate court orders disclosure of contractors’ EEO-1 Reports

The Ninth Circuit rules that FOIA does not protect data from disclosure.  As we previously reported, the Center for Investigative Reporting and its reporter Will Evans are battling the U.S. Department of Labor over its...more

Perkins Coie

Delayed EU Code of Practice Provides Compliance Framework for General-Purpose AI Models

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Key Takeaways - - The European Commission published its Code of Practice for General-Purpose AI (GPAI) Models on July 10, 2025, following three draft versions and just weeks before the first AI Act obligations take effect....more

Cozen O'Connor

FDA Transparency Push: CRLs Released

Cozen O'Connor on

On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more

Ropes & Gray LLP

FDA Commissioner Makary Promises “Real Time” Release of Complete Response Letters: Can FDA Really Do That?

Ropes & Gray LLP on

On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more

Hudson Cook, LLP

New Residential Property Management Laws: Leasing Compliance Shifts for Summer 2025

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With the summer wave of state legislative adjournments ending, residential property managers are confronting a new landscape of regulatory obligations. Several states and municipalities have enacted or finalized laws and...more

Akin Gump Strauss Hauer & Feld LLP

FDA Opens the Vault on Decision Letters—Releases Wave of Drug and Biologic CRLs

This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs...more

Goodwin

FDA’s Push for “Radical Transparency”: Key Takeaways from the Agency’s Publication of Complete Response Letters

Goodwin on

On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced publication of over 200 complete response letters (CRLs) issued in response to applications submitted to FDA for approval of drugs or biologics between...more

Paul Hastings LLP

UK Equity Capital Markets Insights — July 2025

Paul Hastings LLP on

As noted in the April edition of this newsletter, the FCA consulted in February 2024 and November 2024 on proposed measures to update and streamline its enforcement guide and to increase transparency in how it goes about...more

Verrill

Maine Law Now Requires Limited Disclosures of Artificial Intelligence Technology

Verrill on

Maine has joined the list of U.S. states requiring disclosures of Artificial Intelligence (A.I.) technologies. This is due to a new law signed by Governor Janet Mills on June 12, 2025, the Act to Ensure Transparency in...more

A&O Shearman

EC adopts amendments to transparency requirements under MiFIR Review

A&O Shearman on

The European Commission has adopted a Commission Delegated Regulation to amend regulatory technical standards (RTS) on transparency requirements. The MiFIR Review revised the Markets in Financial Instruments Regulation...more

Association of Certified E-Discovery...

Navigating eDisclosure in the UK: Practice Direction 57AD, Scope, Challenges and a New Era

In October 2022, the UK legal system marked a significant evolution in its approach to disclosure with the implementation of Practice Direction 57AD (PD57AD). This directive, applicable to the Business and Property Courts of...more

Hogan Lovells

AI legislative updates in Maine and New York

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On June 12, 2025, Maine Governor Janet Mills signed into law “An Act to Ensure Transparency in Consumer Transactions Involving Artificial Intelligence,” which will impose transparency requirements on the use of artificial...more

Epiq

Class Action Fairness Act Mailings 20 Years Later: Continuity and Evolution

Epiq on

One of the mandates of the Class Action Fairness Act (CAFA) of 2005 was to provide greater visibility into settlements with the goal of generating more transparency on how these settlements affect class members, according to...more

Goodwin

California’s AB 2013: Generative AI Developers Must Show Their Data

Goodwin on

California Assembly Bill 2013 (AB 2013), known as the Generative Artificial Intelligence: Training Data Transparency Act, was signed into law on September 28, 2024, and is set to take effect on January 1, 2026. ...more

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