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McDermott Will & Emery

Preparing for 2025: Key Trends in FDA Guidance Agendas

McDermott Will & Emery on

In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities,...more

Mintz - Health Care Viewpoints

FDA Continues Push to Improve Food Labeling Practices in the United States

In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more

Holland & Knight LLP

RFK Jr.'s 2 Days in the Spotlight: Food Additives, Vaccines and Clinical Trials

Holland & Knight LLP on

Although Robert F. Kennedy Jr.'s nomination hearings to be the Secretary of the U.S. Department of Health and Human Services (HHS) focused on a variety of areas, his testimony and questions from U.S. senators focused on a few...more

Sheppard Mullin Richter & Hampton LLP

FDA Dumps Trio of Device-Related Guidances Prior to Administration Change

Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more

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FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety,...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FDA and OHRP Issue Draft Guidance on Including Biopsies in Clinical Trials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the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more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FDA Releases Draft Guidance on the Labeling of Plant-Based Foods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The U.S. Food and Drug Administration (FDA) recently published draft guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods (Draft Guidance). The Draft Guidance recommends best practices for naming...more

DLA Piper

Navigating China's Healthcare Compliance Landscape: New Guidelines to Mitigate Commercial Bribery Risks

DLA Piper on

China's State Administration for Market Regulation (SAMR) has released the draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (Draft Guidelines) for public comment. The Draft Guidelines,...more

Sheppard Mullin Richter & Hampton LLP

New Accelerated Approval Guidance Underscores Need for Accountability

On December 5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and...more

A&O Shearman

European Commission Publishes Draft FAQs on EU Taxonomy Regulation

A&O Shearman on

The European Commission has published a draft notice containing a set of FAQs on the interpretation and implementation of certain legal provisions of the EU Taxonomy Environmental Delegated Act, the EU Taxonomy Climate...more

A&O Shearman

EDPB calls for alignment between GDPR and EU digital legislation; adopts draft Guidelines on data transfers to third country...

A&O Shearman on

On December 2 – 3 2024, the European Data Protection Board (EDPB) met for its 99th plenary session. It subsequently issued several documents, one of which calls for the need for greater alignment between the GDPR and EU...more

A&O Shearman

UK Financial Conduct Authority Begins Process of Appointing a UK Bond Consolidated Tape Provider

A&O Shearman on

The U.K. Financial Conduct Authority has announced that it is starting the process of appointing a bond consolidated tape (CT) provider. It has published a concession notice that sets out the FCA's next steps for running the...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

Draft UK Greenhouse Gas Emissions Trading Scheme (Amendment) (No. 2) Order 2024 Published

A&O Shearman on

The draft U.K. Greenhouse Gas Emissions Trading Scheme (Amendment) (No. 2) Order 2024 have been published, together with an explanatory memorandum. The Order makes changes to the U.K. Emissions Trading Scheme, including the...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

Pillsbury Winthrop Shaw Pittman LLP

Department of Commerce Releases Five Products to Help Guide AI Development

The Department of Commerce released three final guidance documents incorporating public comments from earlier this spring which provide recommendations for managing AI risk, securing AI software development processes, and...more

Alston & Bird

CPPA Board Declines to Advance CCPA Regulations to Formal Rulemaking; CPPA Highlights Enforcement Priorities

Alston & Bird on

On July 16, 2024, the California Privacy Protection Agency (the “CPPA”) board declined to advance to formal rulemaking California Consumer Privacy Act (“CCPA”) draft regulations on cybersecurity audits, risk assessments,...more

Mitchell, Williams, Selig, Gates & Woodyard,...

FY 2025-2026 Draft National Program Guidance/U.S. EPA Office of Enforcement and Compliance Assurance: National Association of...

The National Association of Clean Air Agencies (“NACAA”) sent a June 10th letter to the United States Environmental Protection Agency (“EPA”) providing comments on the federal agency’s FY 2025-2026 National Program Guidance...more

Jones Day

FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices

Jones Day on

The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions....more

Polsinelli

Revisiting Government March-In Rights Under Bayh-Dole: The FTC Weighs In

Polsinelli on

On February 6, 2024, the Federal Trade Commission (“FTC”) commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act in response to the release of the National Institute...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

Quarles & Brady LLP

FDA Releases Draft Interim Guidance on Bulk Drug Substances in Compounding Under Sections 503A and 503B of FDCA

Quarles & Brady LLP on

The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...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

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