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Katten Muchin Rosenman LLP

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

Stikeman Elliott LLP

Streamlining NI 43-101: CSA Propose to Modernize and Overhaul Canada’s Mining Disclosure Regime

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The Canadian Securities Administrators (“CSA”) have published for comment proposed amendments to National Instrument 43-101 Standards of Disclosure for Mineral Projects (“NI 43-101”), Form 43-101F1 Technical Report (“Form...more

Morgan Lewis - As Prescribed

FDA Extends Scrutiny Over Color Additives Beyond Food to Drug Products

FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more

Sheppard Mullin Richter & Hampton LLP

FedRAMP 20x – Update on Significant Change Process and Assessment Scope Standards

Last month, the federal government announced a major overhaul of the Federal Risk and Authorization Management Program (“FedRAMP”) called “FedRAMP 20x”. FedRAMP 20x is moving forward fast – with new authorizations, community...more

A&O Shearman

FCA Primary Market Bulletin No. 55

A&O Shearman on

The UK Financial Conduct Authority (FCA) has published issue 55 of its Primary Market Bulletin (PMB 55). In PMB 55, the FCA: (i) provides feedback on its consultation in PMB 53, finalises 44 technical and procedural notes,...more

A&O Shearman

SRB consultation on operational guidance on resolvability testing for banks

A&O Shearman on

The Single Resolution Board (SRB) has opened a consultation on its operational guidance on resolvability testing for banks under the SRB's remit. It aims to ensure that European banks are regularly testing their capabilities...more

Best Best & Krieger LLP

EPA Seeks Public Input on WOTUS Implementation Post-Sackett Ruling

On March 24, 2025, the Environmental Protection Agency (EPA) published plans to seek stakeholder input on implementing a new definition of “waters of the United States” (WOTUS) under the Clean Water Act (CWA). The EPA’s goal...more

Sheppard Mullin Richter & Hampton LLP

FedRAMP Releases New Draft Authorization Boundary Guidance

Over the last few years, the Federal Risk and Authorization Management Program (“FedRAMP”) Program Management Office (“PMO”) has released two draft guidance documents related to defining the applicable boundary for security...more

Morgan Lewis - Well Done

FDA Issues Guidance on Foods Made from Genome-Edited Plants in Newest Update to Its ‘Plant-Based Cookbook’

The US Food and Drug Administration (FDA) issued final guidance titled Foods Derived from Plants Produced Using Genome Editing (Genome-Edited Plants Guidance), describing the agency’s approach for evaluating the safety of...more

Latham & Watkins LLP

OCC Proposes Updates to Large Bank Recovery Planning Guidelines

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OCC-supervised institutions with $100 billion or more in average total consolidated assets must be adequately prepared to mitigate severe financial and non-financial risks. ...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Navigating Inventorship of AI-Assisted Inventions: USPTO's Guidance and Implications

This article discusses the February 13, 2024 guidance issued by the United States Patent and Trademark Office (USPTO) regarding the inventorship of artificial intelligence (AI)-assisted inventions. While this guidance marks a...more

McDermott Will & Emery

PTO Reopens Comment Period for AI Inventorship Guidance

McDermott Will & Emery on

The US Patent & Trademark Office (PTO) reopened and extended until June 20, 2024, the period for public comment on the guidance regarding inventorship in applications involving artificial intelligence (AI) assisted...more

McDermott Will & Emery

PTO Proposes New Guidelines for Director Review in Board Proceedings

McDermott Will & Emery on

The US Patent & Trademark Office (PTO) proposed new rules governing the process for Director review of Patent Trial & Appeal Board decisions in America Invents Act (AIA) proceedings. Rules Governing Director Review of Patent...more

BakerHostetler

Key Export Control Developments During the First Quarter of 2024

BakerHostetler on

The first quarter of 2024 saw numerous developments on the export control front. This report summarizes the key developments and provides links to the relevant Federal Register notices and/or agency announcements....more

Foley Hoag LLP - Energy & Climate Counsel

IRS Issues Guidance and Requests Comment on Provisional Emission Rate Process for Hydrogen Tax Credit

On April 10, 2024, Department of Treasury and the Internal Revenue Service (collectively, “IRS”) issued further guidance on the “Provisional Emission Rate” or “PER” process for the Inflation Reduction Act’s (“IRA”) Hydrogen...more

Barnea Jaffa Lande & Co.

MiCA and Reverse Solicitation

Non-EU or non-MiCA compliant entities that want to offer or provide crypto-asset services to clients in the EU must be aware of the newly drafted guidelines from the European Securities and Markets Authority (ESMA). The...more

Hudson Cook, LLP

CFPB Bites of the Month - March 2024 - Here Comes the Sun and the CFPB

Hudson Cook, LLP on

In this month's article, we share some of our top "bites" covered during the March 2024 webinar. Bite 10: CFPB Issues Statement on Privacy and Personal Data - On February 28, 2024, the CFPB issued a statement on...more

Williams Mullen

UPDATE: Virginia Department of Environmental Quality Releases Virginia Stormwater Management Handbook

Williams Mullen on

On March 18, 2024, we issued an alert addressing Virginia Department of Environmental Quality’s (VDEQ’s) recently proposed Virginia Stormwater Management Handbook, Version 1.0 (Handbook). The proposed Handbook is available...more

McDermott Will & Emery

PTO Issues Guidance, Request for Comment on AI Inventorship

McDermott Will & Emery on

On February 13, 2024, the US Patent & Trademark Office (PTO) issued a notice with examination guidance and request for comment regarding inventorship in applications involving artificial intelligence (AI)-assisted inventions....more

Foley Hoag LLP

PTO Provides Guidance on Inventions Created with Help from Artificial Intelligence

Foley Hoag LLP on

On February 13, 2024, the USPTO (PTO) published its guidance for inventions made with the assistance of artificial intelligence (AI). The PTO published the guidance in response to the directive it received in the Executive...more

WilmerHale

USPTO Issues Guidance for AI-assisted Inventions

WilmerHale on

On February 12, 2024, the United States Patent and Trademark Office (USPTO) announced guidance and a request for comments regarding evaluating inventorship for artificial intelligence (AI) assisted inventions (the “AI...more

Holland & Knight LLP

USPTO Issues New Guidance on AI-Assisted Inventorship

Holland & Knight LLP on

The U.S. Patent and Trademark Office (USPTO) issued new guidance on Feb. 12, 2024, regarding the use of artificial intelligence (AI) while developing new inventions. The U.S. Court of Appeals for the Federal Circuit...more

Goodwin

USPTO Issues New Guidance on Patenting AI-Assisted Inventions

Goodwin on

On Monday, the US Patent and Trademark Office (USPTO) issued guidance on the patentability of inventions developed with the assistance of artificial intelligence (AI). This guidance, which was published in the Federal...more

Sheppard Mullin Richter & Hampton LLP

From Good Reprint Practices to SIUU Communications: What Firms Need to Know

On October 23, 2023, the Food and Drug Administration (“FDA”) published a new draft guidance, titled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

Stikeman Elliott LLP

Update on Abuse of Dominance: New Competition Bureau Guidance and First Private Access Application

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The Competition Bureau’s new guidance on and the amendments to the abuse of dominance provisions in the Competition Act significantly expand the scope of these provisions. These developments, coupled with private access to...more

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