FDA’s Morrison Says ORA Reorganization Will Mean More Foreign Inspections

The FDA pharmaceutical investigator of tomorrow will be more specialized by training and more likely to work abroad, a high-ranking agency official told the FDAnews regulatory conference.

Speaking at the 12th Annual FDA Inspections Summit, FDA Assistant Commissioner Ellen Morrison said the future of the ORA is in foreign inspections. Morrison is in charge of medical products and tobacco operations in the Office of Regulatory Affairs.

Investigators and other staffers also will be less likely than their counterparts today to have risen through the ranks and more likely to be experts hired from outside the agency, Morrison said. And future inspectors will be adopting more sophisticated information technology as they potentially move toward an “e-inspect” model, she said.