U.S. Food and Drug Administration Issues NIR Guidance


On August 6, 2021, the U.S. Food and Drug Administration (FDA) released final guidance regarding near-infrared (NIR) analytical procedures. The guidance applies to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs for small-molecule drugs. The FDA will address recommendations for NIR methods used in biologics under a future revision of the guidance.

The new guidance provides the agency’s recommendations for the development, validation, and use of NIR-based analytical procedures in evaluating a drug product’s identity, strength, quality, purity, and potency. The recommendations address the application of concepts described in FDA and International Council for Harmonization guidelines to NIR analytical procedures that use chemometric models. It also discusses submitting NIR documentation in applications.

The guidance does not discuss the development and validation of NIR analytical procedures or the setup, qualification, maintenance, or calibration of NIR instruments. The concepts of the guidance can be applied to other analytical technologies.

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