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.
Get essential updates on the latest spectroscopy technologies, regulatory standards, and best practices—subscribe today to Spectroscopy.
Rapid Sweetener Detection Achieved Through Raman Spectroscopy and Machine Learning
July 10th 2025Researchers at Heilongjiang University have developed a rapid and accurate method for detecting sweeteners in food using Raman spectroscopy combined with a Random Forest machine learning algorithm, offering a powerful tool for improving food safety.
PNNL and BaySpec Launch Compact Mass Spectrometry System for Rapid Narcotics Detection
July 8th 2025The U.S. Department of Energy’s Pacific Northwest National Laboratory’s (PNNL) VaporID, which is a newly developed portable air sampling system incorporating a miniaturized mass spectrometer (MS), can detect trace levels of fentanyl, methamphetamine, cocaine, and even explosives like TNT with great accuracy.
How Spectroscopy Drones Are Detecting Hidden Crop Threats in China’s Soybean Fields
July 8th 2025Researchers in Northeast China have demonstrated a new approach using drone-mounted multispectral imaging to monitor and predict soybean bacterial blight disease, offering a promising tool for early detection and yield protection.