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.)