08.15.24 -- Your Molecule May Be Ready, But What About Your Device?

Waiting until the end of Phase 3 to start planning an E/L testing program can lead to increased costs and delays, stemming from poor assessments that are questioned by the reviewer or incomplete submissions that require the drug company to redo or execute additional work. Learn what you need to know about planning to mitigate delays.

With accelerated approval times, growing competition between drugs, and a shift from hospital to home care — you’re under pressure to develop a delivery device in parallel with your drug: one that’s both patient-centric and easy to use, all while mitigating risk and navigating a complex regulatory landscape.

This study aims to better understand how patients and health care providers perceive and consider using patient-administered medicines to manage chronic conditions. Review resources patients need to increase confidence in starting to use self-injectables and on-body delivery systems to help manage chronic conditions.

Your molecule may be ready, but what about your device? You’ve spent years developing a new molecule that improves patients’ lives. But to deliver on the value, it’s advantageous to select a drug-delivery device that’s a differentiator and meets the standards of patients and regulators alike — right from the start.

Developing a combination product and seeking a list of tests to complete design verification testing? The tests for each combination product must be derived from holistic Risk Assessment processes, with considerations for both drug and device. On the device side, the list of tests will be reflected in the Design Inputs.