FDA releases revised draft guidance on drug delivery device performance
The FDA announced the availability of a revised draft guidance published October 30, 2026. The guidance replaces the draft guidance announced July 1, 2024 and provides recommendations for development and organization of device drug-delivery performance information.
Primary source
Federal Register notice, October 30, 2026
Essential Drug Delivery Performance Characteristics for Devices Intended To Deliver Drugs and Biological Products; Revised Draft Guidance for Industry; Availability
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