Medical Device Legal News with Sam Bernstein: Episode 11
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
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
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
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issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more
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
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the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more
The U.S. Food and Drug Administration (FDA) recently published draft guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods (Draft Guidance). The Draft Guidance recommends best practices for naming...more
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
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5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and...more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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