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Posted 06 September 2013 | By Alexander Gaffney, RAC,
In response to "unparalleled challenges" posed by advances in science, globalization and product complexity, the US Food and Drug Administration (FDA) is preparing to launch a new working group intended to adapt the agency to face current and future challenges.
The working group, known as the Program Alignment Group (PAG), will be comprised of executive-level members of every center in FDA, including the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH) and the Office of Regulatory Affairs (ORA).
"It is imperative that there be greater clarity and transparency about relative roles and responsibilities of the Directorates, ORA, and the Centers, as well as greater operational and program alignment among these organizations that avoids duplication of function and effort, if FDA is going to succeed in the future," the agency wrote in a memorandum distributed to high-level staff and obtained by Focus.
"More specifically, we need to transition to distinct commodity-based and vertically-integrated regulatory programs with well-defined leads, coherent policy and strategy development, well-designed and coordinated implementation, and a de-layered management structure," FDA added.
For now, the PAG is still very much in its infancy, having only been announced on 6 September 2013 by CDER Director Janet Woodcock and FDA Commissioner Margaret Hamburg.
The agency has, however, mapped out six core "initial areas" for the PAG to work on. Per the memorandum, those areas are:
"To successfully implement these initial changes will take time, commitment, continued investment and evaluation, unity, and my support," Hamburg wrote in her memorandum. Initial appraisals of future opportunities will be generated within the next three months.
h/t to Peter Pitts at DrugWonks
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