Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug June 2026

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-clinical-trial-datasets-evaluate-impact-immunogenicity-pharmacokinetics-drug?utm_medium=email&utm_source=govdelivery FDA Announces the Availability of the Technical Specifications Document “Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug” Today, the U.S. Food and Drug Administration (FDA) announced the availability of a technical specifications document Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug. The specifications detailed in this guidance were built to support the data standards and processes described in the technical specifications document Study Data Technical Conformance Guide (March 2026). Evaluating immunogenicity risk and its clinical impact, particularly its effect on pharmacokinetics, is essential for fully characterizing the safety and efficacy of a biological product. To support the regulatory evaluation of immunogenicity data, this technical specifications document describes the desired content and format specifications for three datasets: Analysis Dataset for Immunogenicity Specimen (ADIS), Analysis Dataset for Pharmacokinetic Concentrations (ADPC), and Subject Level Analysis Dataset (ADSL). These specifications will enable efficient analysis and data traceability, as well as facilitate IND-stage discussions between the sponsor and the review team regarding issues with trial design or conduct that may affect the content of the analysis datasets.