US FDA Guidance for Industry Oct-Dec 2025

DateTitle of guidance and link to documentType and level
of guidance		About the guidance
2 Dec 2025Monoclonal Antibodies: Streamlined Nonclinical Safety StudiesDraftThe purpose of this guidance is to assist sponsors in implementing streamlined approaches for nonclinical safety assessments of monoclonal antibodies that recognize a single molecular target,
referred to as monospecific antibodies. Most antibodies are pharmacologically active in nonhuman primates (NHPs) only, and this guidance is intended to facilitate drug development for monospecific antibodies while avoiding unnecessary use of animals, particularly NHPs, consistent with the 3R principles of reducing, refining, and replacing animal testing. By reducing animal testing and incorporating an integrated knowledge-based risk assessment, this guidance is anticipated to facilitate greater efficiencies in product development.
2 Dec 2025QTc Information in Human Prescription Drug and Biological Product LabelingFinalThis guidance:
• is intended to assist applicants with incorporating heart rate-corrected QT (QTc) interval prolongation-related information into the labeling of non-antiarrhythmic human prescription drug and biological products.
• provides recommendations to help ensure that clinically relevant information on QTc interval prolongation
is included in and
distributed appropriately across sections of labeling, in accordance with regulatory requirements for the content and format of human prescription drug labeling.
• provides illustrative examples of the content and format of QTc interval
prolongation-related information in the labeling involving a fictitious subject drug (e.g., DRUGX (drugozide) tablets).
28 Nov 2025Q3E Guideline for Extractables and LeachablesDraft, Level 1This guideline presents a holistic framework and process for the assessment and control of leachable impurities to further expand the existing ICH guidelines on impurities, including impurities in new drug substances (ICH Q3A) and new drug products (ICH Q3B), residual solvents (ICH Q3C), and elemental impurities (ICH Q3D), as well as DNA reactive (mutagenic) impurities (ICH M7).

The guideline applies to the risk assessment and control of leachables in new drug products, including cell and gene therapy products. Drug-device combination products that require marketing authorizations and meet the definition of pharmaceutical or biological products are also in scope.
28 Nov 2025QE3 Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable MonographsDraft, Level 1
29 Oct 2025Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies

Further reading:
1) FDA relaxes biosimilars guidance, Catherine Drew et al, 4 November 2025, Pinsent Masons

2) FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs, 29 Oct 2025, FDA		Draft This draft guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints (a “comparative efficacy study” or “CES”) to support a demonstration of
biosimilarity in a biologics license application (BLA) submitted under section 351(k) of the Public Health Service (PHS) Act.
23 Oct 2025Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome AssessmentsFinal, Level 1This guidance (Guidance 3) is the third in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders (patients, caregivers,
researchers, medical product developers, and others) can collect and submit patient experience data and other relevant information from patients, caregivers, and clinicians to be used for medical product development and regulatory decision-making.
22 Oct 2025Expanded Access to Investigational Drugs for Treatment Use: Questions and AnswersLevel 1 Revised GuidanceThis guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on expanded access
to investigational drugs for treatment use under an investigational new drug application (IND) (21 CFR part 312, subpart I), which went into effect on October 13, 2009