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How FDA classifies high‑risk and non‑high‑risk products under ICH M13A
Summary
An agency official explained the FDA framework for classifying solid oral immediate‑release products: factors include solubility/BCS, formulation/manufacturing complexity, critical excipients in the RLD, and dosing/food instructions, all of which determine recommended BE studies.
The presenter walked through the FDA framework used to categorize products as high‑risk or non‑high‑risk under ICH M13A. She listed the primary criteria: biopharmaceutic properties such as solubility and BCS class; formulation design and manufacturing complexity (for example, solid dispersions, microemulsions, or nanotechnologies); critical excipients in the RLD (surfactants, solubility enhancers); and dosing or food‑effect instructions on the RLD label.
She emphasized the RLD formulation and label are the starting point for FDA's initial risk assessment, but that the agency may change classification after reviewing the ANDA if the generic formulation includes complex methods or different critical excipients that could cause differing in vivo outcomes.
