FDA Newly Added Guidance

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FDA Draft Guidance on Bayesian Methodology in Drug Trials

The FDA has issued draft guidance on the use of Bayesian methodology in clinical trials for drug and biological products.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FDA Draft Guidance: Common Technical Document for Quality

The FDA has released draft guidance on the Common Technical Document (CTD) for the quality section of pharmaceutical registration applications.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FDA Draft Guidance on Patient Preference Studies

The FDA has released draft guidance on general considerations for patient preference studies, developed under the International Council for Harmonisation (ICH). The agency is accepting public comments on this draft guidance until April 7, 2026.