In late December, the U.S. FDA’s CDER office released its 2016 priorities. These include renegotiating parts of PDUFA and GDUFA, a continuing focus on drug compounding and furthering implementation of Track and Trace.
CDER Director Janet Woodcock also
outlined the Center’s 2015 accomplishments.
During the past year, CDER stabilized
the new Office of Generic Drugs,
completed the standup of the Office of
Pharmaceutical Quality, established multiple
guidances pertaining to pharmacy
compounding and responded to congressional
queries related to the 21st Century