FTC Draft Rulemaking on Negative Option Plans Submitted for Review

The FTC has submitted a draft Advance Notice of Proposed Rulemaking (ANPRM) concerning its Negative Option Rule to the Office of Management and Budget (OMB) for review. This action indicates the agency is considering potential revisions or new regulations related to negative option plans, which are common in subscription services.

FTC Warns 42 Law Firms on Anticompetitive DEI Hiring Practices

The FTC has issued warning letters to 42 law firms regarding potentially anticompetitive employment practices related to Diversity, Equity, and Inclusion (DEI) hiring. The firms, which participated in the Mansfield Certification program, are cautioned that coordinating on candidate pools or sharing pay information may violate antitrust laws.

ICO Enforcement Actions

The UK's Information Commissioner's Office (ICO) has published a list of its enforcement actions, including monetary penalties, prosecutions, and reprimands. This page serves as a central repository for these actions across various sectors.

ICO FOI Regulatory Actions

The Information Commissioner's Office (ICO) has updated its Freedom of Information (FOI) regulatory actions page. This update includes new notices, recommendations, and practice guidance related to FOI compliance for public authorities in the UK.

ICO Recovers Fines and Issues Penalties to DPP Law, 23andMe, Capita

The UK's Information Commissioner's Office (ICO) has recovered fines and issued penalties to several organisations, including DPP Law, 23andMe, and Capita. The ICO details its formal debt recovery actions, which can lead to insolvency proceedings and director disqualifications for non-payment of fines.

FDA Guidance on Promotional Labeling for Biosimilar Products

The FDA has issued new guidance addressing promotional labeling and advertising considerations for prescription reference products, biosimilar products, and interchangeable biosimilar products. The guidance aims to ensure promotional communications are accurate, truthful, and non-misleading for manufacturers and their representatives.

FDA Finalizes Guidance on Drug Dispute Resolution

The FDA has finalized guidance for industry on formal dispute resolution and administrative hearings for drugs subject to final administrative orders under section 505G of the FD&C Act. This guidance provides recommendations for resolving scientific and medical disputes between the Center for Drug Evaluation and Research (CDER) and drug sponsors.

FDA Draft Guidance on Bayesian Methodology in Drug Trials

The FDA has issued draft guidance on the use of Bayesian methodology in clinical trials for drug and biological products. This guidance is intended for sponsors and applicants and focuses on supporting primary inference for effectiveness and safety. The agency is seeking public comments on this draft document.

FDA Draft Guidance: Common Technical Document for Quality

The FDA has released draft guidance on the Common Technical Document (CTD) for the quality section of pharmaceutical registration applications. This guidance, developed under the International Council for Harmonisation (ICH), aims to harmonize the organization and presentation of quality data for human use pharmaceuticals. Comments on the draft are due by March 23, 2026.

FDA Draft Guidance on Patient Preference Studies

The FDA has released draft guidance on general considerations for patient preference studies, developed under the International Council for Harmonisation (ICH). The agency is accepting public comments on this draft guidance until April 7, 2026.