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FDA plans revamp of drug probe centre


The FDA has awarded a two-year contract to a Californian university to help transform the regulator’s Center for Drug Evaluation and Research (CDER).

The Center for Professional Development (CPD) at California State University, East Bay, will be tasked with initiating steps to improve workplace leadership, empower staff and establish more effective business practices within the organisation.

The move is part of the FDA’s ongoing response to a 2006 report by the Institute of Medicine (IOM), the US national academy of medicine.

The report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, identified workplace culture issues at the CDER and recommended that external management consultants be employed to develop a comprehensive strategy to address them.

Under the contract, CPD will help to develop practical strategies, including training, tools and processes, which the FDA hopes will strengthen CDER’s effectiveness and “reaffirm its mission of advancing and protecting the public health”.

Janet Woodcock, FDA deputy commissioner for scientific and medical programmes, chief medical officer and acting centre director, said: “This transformative programme will provide CDER with the tools and expertise necessary to create a sustainable environment of open and transparent communication, collaborative decision-making, and improved morale and staff retention.”

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IOM report

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