Just
over
a
year
ago,
the
U.S.
FDA
released
detailed
information
about
the
restructuring
of
the
newly
realigned
Office
of
Regulatory
Affairs
(ORA)
(1).
Alonza Cruse,
Director,
Office
of
Pharmaceutical
Quality
Operations,
ORA,
provided
an
update
on
this
and
other
ORA
initiatives
on
Sept.
24
in
the
second
plenary
of
the
2018 PDA/FDA Joint Regulatory Conference.