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.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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