Illustration of a prefilled syringe held between specification limit lines, representing essential drug delivery performance characteristics in FDA's revised draft guidance.

Essential Drug Delivery Performance Characteristics: FDA’s Revised Draft, and What Moved Since 2024

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FDA’s revised draft guidance on essential drug delivery performance characteristics (30 October 2026) renames EDDOs as EDDCs, rewires verification and control strategy expectations, and aligns with the QMSR. What changed since 2024, and what to comment on before 28 January 2027.

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