06.04.25 -- Are Your Combination Products Ready For Tomorrow's Regulations?

The market for injectables has experienced consistent growth over the past decade, with projections indicating continued strong expansion. Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.

The FDA released draft guidance that introduces and defines new terminology, clarifying the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements. The current draft reflects the FDA's latest thinking, so all future submissions are expected to align with its recommendations.

When developing combination products or evaluating primary packaging for drug products, one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose. Learn more about conducting tests that simulate real-world conditions based on the intended use of the device or packaging.

The combination product market is consistently expanding, largely due to the increasing prevalence of chronic diseases, the demand for self-administered treatments, and advancements in drug delivery devices. Transitioning from traditional vial systems to needle-based combination products presents several challenges that require careful consideration.

The final stage in assessing drug packaging involves identifying the actual leachables present in the drug throughout its shelf life. It's crucial to develop and validate analytical methods capable of detecting a wide range of potential leachables specific to the drug and its packaging. See how updated guidelines affect development and validation.

The USP requirements for elastomeric components of container closure systems used for parenteral products are changing. The scope of USP <382> introduces a shift to a holistic evaluation of components when assembled into drug product packaging and delivery systems. Explore the implications for vial, syringe, and cartridge container closure systems.