United States

FDA Draft Guidance on Bayesian Methodology in Drug Trials

The FDA has issued draft guidance on the use of Bayesian methodology in clinical trials for drug and biological products.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FDA Draft Guidance: Common Technical Document for Quality

The FDA has released draft guidance on the Common Technical Document (CTD) for the quality section of pharmaceutical registration applications.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FDA Draft Guidance on Patient Preference Studies

The FDA has released draft guidance on general considerations for patient preference studies, developed under the International Council for Harmonisation (ICH). The agency is accepting public comments on this draft guidance until April 7, 2026.

Gerard v. Cuevas - Unlawful Detainer Rent Case Opinion

This document is an opinion from a California court regarding an unlawful detainer rent case, Gerard v. Cuevas. It provides a judicial interpretation of relevant housing and landlord-tenant laws.

Bartholomew v. Parking Concepts, Inc. - Civil Litigation

This document pertains to the civil case Bartholomew v. Parking Concepts, Inc., case number A171546, filed in a US court. The filing represents a new addition to the court's docket, initiating legal proceedings between the named parties.

Esparza v. Superior Court Case Information

This notice provides case information for Esparza v. Superior Court, identified by case number E085807. The update is from the California Courts Appellate Cases system. No specific compliance actions or deadlines are detailed.

Florida man pleads guilty to biofuel fraud conspiracy

Florida man pleads guilty to biofuel fraud conspiracy

Antifa member arrested for cyberstalking, threatening ICE officers

Antifa member arrested for cyberstalking, threatening ICE officers

Florida man sentenced to 48 months for tax evasion

Florida man sentenced to 48 months for tax evasion

Defendant pleads guilty to international human and drug smuggling conspiracy

Defendant pleads guilty to international human and drug smuggling conspiracy