FDA issues revised draft guidance for drug-device combination product performance

The U.S. Food and Drug Administration has released a revised draft guidance aimed at helping sponsors of drug-device combination products develop essential drug delivery device performance characteristics (EDDCs). The document outlines expectations for performance testing, risk assessment and documentation to support product safety and efficacy.

The guidance is intended to provide clearer pathways for designing and validating the performance of delivery devices that are integral to the drug product.

Separately, the Department of Health and Human Services announced that it will not take enforcement action against state‑licensed pharmacies, federal facilities, or licensed physicians that compound six specific unapproved peptide bulk drug substances, as long as they follow conditions set out in an interim policy.

This interim policy remains in place until a formal rulemaking process is completed, offering temporary regulatory certainty for compounding operations.