The FDA has announced a revised draft guidance for industry titled “Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products.” This guidance replaces the previous draft guidance from July 1, 2024. It addresses critical aspects of drug delivery performance information for devices and combination products that include device constituent parts intended for the delivery of human drugs, including biological products. The guidance aims to provide recommendations for the development and organization of device drug-delivery performance information and data, enhancing the consistency of this information in applications. This initiative is designed to facilitate transparency and predictability in the development and regulatory review processes, potentially streamlining the lifecycle management of drug delivery devices.
Source: drug-dev.com · Image: Glycerin suppositories by Shattonbury, Public domain, via Wikimedia Commons
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