PDA Letter Article

Novel Drug Products Drive New Views on Suitability

by Diane Paskiet, West, and Ronald Iacocca, PhD, Eli Lilly and Company

The drive for patient-centric solutions and the emergence of novel drug products has led to the need for early understanding of container closure and delivery system suitability. A therapeutic product is fit for use when it meets established quality criteria with appropriate correlations between drug product quality and clinical performance. But when and how should the drug delivery system or drug/device system characteristics be considered? A broad range of challenges related to safety and compatibility must be overcome when qualifying combination products associated with both drugs and devices.


What types of delivery system risks should be considered? How can they be assessed? What data is needed to qualify a combination product?

These will be among the topics of discussion at the 2017 Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop. This event will focus on current topics related to container closure systems and device/drug combination products. Individual components of a system are often regulated under different FDA Centers, each having different policies, practices and timelines. As delivery technologies advance, so too does the need for inter-Center agreements, although the requirements are not clear-cut. Areas of common interest include:

  • Intended use and design inputs
  • Biocompatibility data
  • Design outputs conforming to the design inputs
  • Design verification and validation
  • Translation of the design into manufacturable specifications

FDA representatives will speak to these requirements. Jennifer Goode, Biocompatibility Program Advisor, CDRH, will discuss biocompatibility assessments for devices. CDER’s Susan Kirshner will address biologic compatibility. CDRH’s Nazia Rahman and Isabel Tejero will speak on the impact of supplier controls on delivery system quality. And CDER’s Dan Mellon, PhD, will review the Agency’s extractables and leachables studies.

(Learn more about the 2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop.)