On Monday, December 14th, the director of FDA's Center for Drug Evaluation and Research (CDER), Janet Woodcock, M.D., spoke at the FDA/CMS Summit for Biopharma Executives where she announced the division's top priorities for 2016.
Overview of 2015
Dr. Woodcock began by saying that the Agency has done "pretty well" throughout 2015. She also highlighted a number of the FDA's accomplishments over the past year, drawing attention to many of the "front burner" priorities such as:
In addition to the Agency's successes, Woodcock also highlighted some concerns from 2015, such as the backlog of ANDAs. She stated that FDA experienced a "huge turnaround" this past year, and has exceeded its goals for GDUFA. Furthermore, she said the Agency is interested in reducing the number of review cycles for generic drugs currently trending at about four cycles per drug. , She declared that the ANDA backlog was the biggest challenge of GDUFA I, but stated that FDA is confident it will be able to get through the stockpile of generic applications within the next two years.
View a complete list of CDER's 2015 priorities here.
Priorities for 2016
After touching on the successes of 2015, Woodcock dove into CDER's goals for 2016. She provided an overview of what to expect in the coming year and highlighted a number of "front burner" priorities that CDER plans to tackle, including:
Woodcock included additional concerns as well, categorizing them as "important priorities," "continuing priorities," and "important administrative/managerial priorities." A full list of CDER's 2016 priorities can be found here.
For more information on CDER's goals and priorities for 2016, view Dr. Woodcock's presentation here.
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