FDA’s Mullin Tapped for New Position in CDER’s Office of the Center Director

Posted 05 March 2018 | By Zachary Brennan 

FDA’s Mullin Tapped for New Position in CDER’s Office of the Center Director

FDA announced on Monday that Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER), has appointed Theresa Mullin to the new position of CDER associate director for strategic initiatives in the Office of the Center Director (OCD), effective immediately.

Mullin has led CDER’s Office of Strategic Programs (OSP) for almost a decade and previously led FDA user fee negotiations with the pharmaceutical industry for the 2002 and 2007 reauthorizations of PDUFA.

“In this role, Theresa will oversee areas of strategic interest to external stakeholders. She will continue to lead the Patient-Focused Drug Development (PFDD) initiative, which she has led successfully for five years. This includes work related to the FDA Reauthorization Act (FDARA) and implementation of the 21st Century Cures Act. Theresa will also continue to lead CDER’s International Program, building on recent reforms to the International Council for Harmonization,” an email from Woodcock to staff said.

Politico also reported on Monday that former HHS political appointee Keagan Lenihan is starting this week as FDA associate commissioner for strategic initiatives.

Woodcock added that Mary Ann Slack, OSP’s deputy director, will serve as acting director of OSP while FDA looks to hire a permanent director.

Categories: Regulatory News

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