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USFDA Guidance: Multiple Biologics related Guidance - M10 Bioanalytical Method Validation

This week USFDAs Center for Biologics Evaluation and Research updated and released multiple guidances related to Gene therapy, Oncology, and Bioanalytical Method Validation and Study Sample Analysis.

It is common for oncology drug approvals to enhance treatment efficacy by adding new drugs to existing regimens or by combining investigational drugs into new regimens.

A key purpose of this guidance is to describe FDA’s current recommendations regarding the inclusion of important cross-labeling information for oncology drugs approved for combination regimens.

In this guidance, sponsors are provided with recommendations pertaining to the study of multiple versions of a cellular or gene therapy product in an early-phase clinical trial. FDA provides recommendations on how to conduct studies that evaluate multiple versions of cellular and gene therapy products, including how to structure INDs, submit new data, and report adverse events.

In this guidance, method validation recommendations are given for nonclinical and clinical bioanalytical assays used in regulatory submissions, as well as the procedures and processes that need to be characterized in order to measure the parent and active metabolites of drugs administered to nonclinical and clinical subjects using chromatographic and ligand-binding assays.


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