FDA Newly Added Guidance

Establishing Impurity Specifications for Antibiotics

FDA has published a draft guidance providing recommendations on establishing specifications for organic impurities in antibiotics manufactured by fermentation and semi-synthesis. The guidance applies to antibiotic drugs subject to approval under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and associated type II drug substance drug master files (DMFs), as well as nonprescription antibiotic OTC monograph drugs. Comments may be submitted at any time via Regulations.gov under docket FDA-2025-D-6130.

FDA Draft Guidance on New Approach Methodologies in Drug Development

FDA's Center for Drug Evaluation and Research (CDER) has published draft guidance offering a validation framework and general recommendations for using New Approach Methodologies (NAMs) in drug development regulatory submissions. The guidance aims to reduce reliance on animal testing while improving human relevance and predictivity of nonclinical safety studies. Comments are being accepted on the validation principles outlined for study design and reporting standards.

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FDA Draft Guidance on Bayesian Methodology in Drug Trials

The FDA has issued draft guidance on the use of Bayesian methodology in clinical trials for drug and biological products.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.

M4Q(R2) Common Technical Document Quality Guidance for Human Pharmaceutical Registration

The FDA announced draft guidance M4Q(R2) updating the quality section of the Common Technical Document (CTD) for human pharmaceutical registration. Prepared under the International Council for Harmonisation (ICH), the draft establishes a globally harmonized framework for organizing and presenting quality data in registration applications. Comments are due by March 23, 2026.

E22 General Considerations for Patient Preference Studies

The FDA, through its Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, has issued draft guidance E22 on Patient Preference Studies for public comment by April 7, 2026. The guidance provides general principles for the use, design, conduct, analysis, and submission of patient preference studies in drug development and regulatory evaluation, prepared under ICH auspices. Pharmaceutical companies engaged in drug development and regulatory submissions should review and submit comments before the deadline.