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Katten Muchin Rosenman LLP

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

Katten Muchin Rosenman LLP on

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance.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

Morgan Lewis - As Prescribed

FDA Extends Scrutiny Over Color Additives Beyond Food to Drug Products

Morgan Lewis - As Prescribed on

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 In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more

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

Perkins Coie

NIST Seeks Comment on Proposals to Identify and Manage Bias in Artificial Intelligence

Perkins Coie on

The National Institute of Standards and Technology (NIST) recently published “A Proposal for Identifying and Managing Bias in Artificial Intelligence,” a special publication that is part of a series of documents and workshops...more

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

Epstein Becker & Green on

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

McNees Wallace & Nurick LLC

EEOC Will Cease Collecting EEO-1 Component 2 Pay Data

McNees Wallace & Nurick LLC on

The Equal Employment Opportunity Commission (EEOC) announced on September 11, 2019 that it will not be seeking renewal for collection of EEO-1 Component 2 pay data, which requires employers with 100 or more employees to...more

Hogan Lovells

NRC Publishes Draft Guidance on Advanced Reactor Licensing Basis Development

Hogan Lovells on

The US Nuclear Regulatory Commission (NRC) in early May issued a notice seeking comments on a new draft regulatory guide impacting advanced reactor licensing. ...more

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