Transcript www.ebglaw.com

Adverse Event
Reporting for
Combination
Products
Bradley Merrill Thompson
Leighton Hansel
Colleen Hittle
FDA’s concept paper
• General principles
– For most combination products,
appropriate AE reporting may be achieved
by following the regulatory provisions
associated with the type of marketing
application used for approval.
– But this does leave gaps.
• For example, following the MDR for a
drug/device combination would leave out some
important drug type information.
Differences in AE reporting schemes
• Device malfunction reporting
• Five day MDR reporting
• Drug and biological product
“alert” reporting
• Blood related deaths
FDA’s conceptual alternatives
• Combination products approved under one marketing
application.
– For these, FDA could simply require that the manufacturer follow
the rules associated with the marketing application.
• Combination products approved under separate
marketing applications.
– If both applications filed by the same manufacturer, where the
most likely part associated with the incident can be identified, the
manufacturer would follow the rules associated with that part.
– If not, the manufacturer would follow the rules associated with the
lead review Center.
– If the two applications are filed by separate manufacturers, each
manufacturer would file according to the marketing application
used for the part they made.
– FDA is unsure of what to do when a manufacturer believes that
the other manufacturer has the responsibility.
CPC Comments
• Let’s remember that combination
products come in three flavors:
– Cross labeled
– Kits
– Single entity
• CPC in its comment letter put together a
table showing how interim and unified
safety reporting systems could be
accomplished.
Conceptual alternatives
Option
Basic
rule
1
2
3
File
Always FDA
based
file two should
on the
use
subdiscretion
mission
to decide
or
at the
center
time of
type
approval
4
5
6
The
manufacturer
should
have the
discretion
to decide
which
best
applies
Always
file 1½,
that is a
primary
submission
and a
supplemental
submission
FDA
should
develop
a single
unified
reporting
process
for
combination
products
Questions or comments?
Questions or comments?