CDER gains Woodcock as permanent chief

Much to the surprise of most close FDA observers, Janet Woodcock, MD, agreed in March to resume control of the Center for Drug Evaluation and Research (CDER). Dr Woodcock headed CDER for 10 years before becoming deputy commissioner and, more recently, FDA’s chief medical officer. But when CDER director Steven Galson, MD, MPH, left last year, Dr Woodcock served as the temporary CDER chief. Now, after a long search for a replacement, she has decided to accept the position herself.

Much to the surprise of most close FDA observers, Janet Woodcock, MD, agreed in March to resume control of the Center for Drug Evaluation and Research (CDER). Dr Woodcock headed CDER for 10 years before becoming deputy commissioner and, more recently, FDA’s chief medical officer. But when CDER director Steven Galson, MD, MPH, left last year, Dr Woodcock served as the temporary CDER chief. Now, after a long search for a replacement, she has decided to accept the position herself.

Dr Woodcock returns to the post at a difficult time for the organization. One of CDER’s priorities is to implement the many provisions of the FDA Amendments Act of 2007 (FDAAA), which involves writing new rules and multiple guidances as well as expanding programs and operations on many fronts. The good news is that CDER has added resources to hire approximately 700 additional staff members; the bad news is that the hiring and training process will require considerable time and energy.