Woodcock 2016 Priorities for CDER

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] In mid-December at the FDA/CMS Summit in Washington, DC, CDER Director Janet Woodcock discussed her center’s 2015 achievements and 2016 priorities.  Among the 2015 achievements were: ● meeting and exceeding GDUFA performance goals ● “stabilizing” the new Office of Generic Drugs ● putting in place the new Office of Pharmaceutical Quality ● issuing multiple draft and final guidances on pharmacy compounding ● issuing multiple draft and final guidances ● putting in place the Panorama IT system for workflow management, document and data access, which now hosts the generic drug review process, and ● responding to Congressional requests on “21st Century Cures” legislation.  Woodcock divided 2016 priorities into “front burner,” “important,” and “continuing” categories.  Among the “front burner” priorities are: ● negotiating PDUFA VI, GDUFA II, and BSUFA II ● continuing to implement new and clarified statutory provisions on drug compounding and outsourcing facilities ● continuing implementation of the track and trace program ● continuing to plan for and build out Panorama for the new drug review process and other regulatory functions, and ● filling more than 600 vacant CDER staff positions.
[/membership]