Hogan Lovells

2025 promises to be a transformative year for ESG, with Donald Trump's return to the White House and the potential ESG applications of AI at the top...

The U.S. Food and Drug Administration (FDA) has published final guidance on “Communications From Firms to Health Care Providers Regarding Scientific...

The U.S. Food and Drug Administration (FDA) recently published its long-awaited draft guidance on considerations for the use of artificial intelligence (AI) to support regulatory decision-making for drug and biologics, which provides a comprehensive, risk-based framework to help sponsors evaluate and manage AI models. The guidance applies to the nonclinical, clinical, postmarketing, and manufacturing phases of the product lifecycle; while notably excluding from its scope AI use for drug discovery and operational efficiencies that do not impact patient safety, drug quality, or the reliability of results from a nonclinical or clinical study. By implementing the recommended credibility assessment plans and submitting credibility assessment reports as described by the guidance, drug and biologic sponsors can establish robust documentation that validates their AI models for FDA review. The guidance also underscores the importance of continuous oversight of AI through a lifecycle maintenance plan, to ensure that models remain reliable and compliant as new data, technologies, and policies emerge.

On January 14, 2025, the U.S. Food and Drug Administration (FDA) issued its proposed rule on front-of-package nutrition labeling (FOPNL).1 With certain exemptions, the proposed rule would require food products to display an informational box on the top third principal display panel (PDP), displaying the percent Daily Value (%DV) for sodium, saturated fat, and added sugars, accompanied by the interpretive markers “High,” “Med,” or “Low,” for each nutrient. Importantly, FDA has not proposed a scheme that includes calories, nor is FDA proposing a scheme where disclosures are reserved for nutrients considered “High.” FDA asserts that the proposed labeling scheme would provide consumers with standardized nutrition information that could help them quickly identify foods they can incorporate into a healthy diet. FDA also proposes amendments to the low sodium and low saturated fat nutrient content claim regulations to align with current nutrition science and avoid within-label inconsistencies. Comments are due May 16, 2025.

A snapshot of key market and regulatory developments expected to impact the UK insurance sector over the next few months.

In the Autumn 2024 Budget, the UK Government announced fundamental changes to the way that carried interest will be taxed in the UK. Major change in this area was expected and there will be a number of qualifying conditions, including an average holding period test to apply from April 2026. However, the changes are not as drastic as many in the UK’s asset management industry had feared.

On 28 June 2025, the key requirements of Directive (EU) 2019/882 – also known as the European Accessibility Act or “ EAA ” – will take effect. The EAA is expected to lift barriers to accessibility across the EU, in turn improving inclusion and facilitating more independent living for people with disabilities (physical and mental) and individuals with other functional limitations (e.g., the elderly).

In September 2024, the U.S. Securities and Exchange Commission (SEC) adopted new rules relating to access to, and management of, EDGAR accounts, including the required use of a new SEC filing platform, “EDGAR Next”. Every SEC filer will need to take the necessary steps to ensure compliance once EDGAR Next goes live on March 24, 2025.

Shortly after being sworn in on January 20, President Trump issued several actions, including issuing executive orders and instructions to agencies, that will affect the regulatory environment facing the food and agriculture industries. “Day One” actions are an increasingly common feature of changes in presidential administrations. Several of President Trump’s actions are consistent with policies from his first term in office, while others reflect recent campaign promises. A number of President Trump’s actions affect the regulatory process directly, including a temporary freeze on rulemaking, and others will have indirect effects on the food industry. We summarize key actions of interest below.1

On January 3, 2025 the U.S. Department of Commerce’s Bureau of Industry and Security released an advanced notice of proposed rule-making seeking...