FDA Reorganizes Regulatory Affairs Office to Respond to Drug Industry Globalization

The FDA is planning to reorganize its Office of Regulatory Affairs (ORA), including creating new offices and reorganizing others, as it takes steps to dissolve cumbersome domestic and international distinctions and to keep up with increasingly global operations.

The restructuring will also better position the ORA to address new legislative authorities included in the FDA Safety and Innovation Act (FDASIA), signed into law this summer, which boosts the FDA’s supply chain oversight and inspection authority while allowing for risk-based approaches to both — major changes that call for “new strategies” and enhanced coordination across the office, according to an agency fact sheet on the ORA reorganization.

Overseeing the reorganization will be a new Office of Operations. The current Assistant Commissioner for Field Operations, Roberta Wagner, will head that office as Assistant Commissioner for Operations.

Also in transition is current Associate Commissioner for Regulatory Affairs Dara Corrigan who will become the director of the FDA’s European office in Brussels and Senior Adviser for Global Operations, FDA spokeswoman Carla Daniels said. Melinda Plaisier, a regional food and drug director in Chicago, will assume Corrigan’s duties in an acting role.

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