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USFDA Draft Guidance: Essential Drug Delivery Performance Characteristics for Drug and Biological Product Delivery Devices
The U.S. Food and Drug Administration (FDA) has issued a revised draft guidance titled “Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products” in October 2026. The document provides recommendations for establishing, evaluating, and maintaining the performance characteristics of devices and combination products used to deliver human drugs, including biological products. 1. Scope and Applicability The draft guidance ap
Sharan Murugan
2 hours ago7 min read