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MoFo Life Sciences

FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety,...

MoFo Life Sciences on

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Ropes & Gray LLP

FDA and OHRP Issue Draft Guidance on Including Biopsies in Clinical Trials

Ropes & Gray LLP on

On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more

Perkins Coie

FDA Releases Draft Guidance on the Labeling of Plant-Based Foods

Perkins Coie on

The U.S. Food and Drug Administration (FDA) recently published draft guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods (Draft Guidance). The Draft Guidance recommends best practices for naming...more

Perkins Coie

Q3 2024: Food & CPG Legal Trends

Perkins Coie on

We are pleased to share our Q3 Food & Consumer Packaged Goods (CPG) Legal Trends report. This report is a bite-size version of our annual year in review, providing timely insights on legal trends in the space. In Q4 of...more

A&O Shearman

Antitrust in focus - September 2024

A&O Shearman on

This newsletter is a summary of the antitrust developments we think are most interesting to your business. James Webber (partner based in London) and Jess Bowring (counsel based in London) are our editors this month. They...more

McDermott Will & Emery

EU Regulators Confirm that Cookie Consent Rules Apply to Much Broader Range of Tracking Technologies

McDermott Will & Emery on

Article 5(3) of the EU ePrivacy Directive (ePD) requires consent for tracking cookies (unless exceptions apply). Although this rule is best known as the reason behind ‘cookie’ banners, it is technology neutral and applies to...more

Fenwick & West LLP

FTC and DOJ Publish Final Revised Merger Guidelines, Driving Increased Uncertainty for M&A Activity

Fenwick & West LLP on

On December 18, 2023, the Federal Trade Commission (FTC) and Department of Justice Antitrust Division (DOJ) (together, the “agencies”) jointly released their final revised 2023 Merger Guidelines, reflecting modest adjustments...more

Skadden, Arps, Slate, Meagher & Flom LLP

DOJ and FTC Release Final 2023 Merger Guidelines Formalizing Aggressive Merger Enforcement Playbook

On December 18, 2023, the Federal Trade Commission (FTC) and Antitrust Division of the Department of Justice (DOJ) released the final 2023 Merger Guidelines (the Guidelines). While the final version of the Guidelines reflects...more

McDermott Will & Emery

New FTC, DOJ Merger Guidelines Create Challenges and Opportunities

McDermott Will & Emery on

The US Federal Trade Commission (FTC) and US Department of Justice Antitrust Division (DOJ) issued their updated Merger Guidelines on December 18, 2023. These guidelines represent a significantly more...more

Sheppard Mullin Richter & Hampton LLP

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more

Hogan Lovells

FDA issues draft guidance on remote regulatory assessments

Hogan Lovells on

DA recently released Draft Guidance on the Agency’s expanded use of remote regulatory assessments (RRAs) to review regulated establishments and / or their records. FDA outlines how it intends this tool to be incorporated...more

Foley Hoag LLP - Cannabis and the Law

Massachusetts Cannabis Control Commission Issues Draft Guidance on Hemp; Public Comments Accepted Through December 15

On November 23, 2021, the Massachusetts Cannabis Control Commission (CCC) released Draft Guidance on Hemp (Draft Guidance). Pursuant to a 2020 amendment, adult-use cannabis establishments licensed by the CCC are permitted...more

Hogan Lovells

EU Commission seeks feedback on implementing the new Market Surveillance Regulation

Hogan Lovells on

The European Commission announced on 22 January 2020 that it is looking for feedback on draft guidelines on the implementation of Article 4 of the Market Surveillance Regulation (EU) 2019/1020 (the "Regulation"). ...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - October 2019

In this month's edition of our Privacy & Cybersecurity Update, we examine the California attorney general's draft regulations on the California Consumer Privacy Act, the CJEU's clarified rulings on the use of cookies, the...more

Hogan Lovells

The Use of an Alternate Name for Potassium Chloride in Food Labeling: Guidance for Industry

Hogan Lovells on

Last week the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual name...more

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