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FDA Draft Guidance on Bayesian Methodology in Drug Trials

The FDA has issued draft guidance on the use of Bayesian methodology in clinical trials for drug and biological products.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FDA Draft Guidance: Common Technical Document for Quality

The FDA has released draft guidance on the Common Technical Document (CTD) for the quality section of pharmaceutical registration applications.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FDA Draft Guidance on Patient Preference Studies

The FDA has released draft guidance on general considerations for patient preference studies, developed under the International Council for Harmonisation (ICH). The agency is accepting public comments on this draft guidance until April 7, 2026.

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.

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.

Engstrom v. United States - Sentencing Reversed

The Ninth Circuit Court of Appeals reversed the sentencing of Paul Engstrom in a drug case. The court found that the district court erred in its application of sentencing enhancements, requiring a resentencing. This decision impacts how certain drug offenses are sentenced within the Ninth Circuit.

Montejo-Gonzalez v. Bondi - Immigration Habeas Corpus

The Ninth Circuit Court of Appeals issued an opinion in Montejo-Gonzalez v. Bondi, addressing a habeas corpus petition related to immigration detention. The court's decision clarifies legal standards applicable to such cases.