FDA’s Office of Regulatory Affairs (ORA) is adapting its training to reflect changing technologies and regulatory approaches, and a bolus of new investigators with divergent experience.
FDA Deputy Associate Commissioner for Field Operations Michael Chappell highlighted the upgrading of ORA’s training in response to these challenges at the mid-September PDA/FDA meeting in Washington, DC.
Chappell noted that ORA has hired approximately 900 new investigators since 2008, including “the highest number of PhDs, MDs, and those with regulatory experience coming from your industry” that have joined FDA in its history.
Having a large number of new investigators with vastly different levels of experience “creates a little bit of a challenge for us,” he explained. Levels of experience range from some “right out of college” to “some that have 20 years of experience in quality assurance in the medical products area, and everything in-between.”
Compounding the challenge of addressing this range of experience is that the new hires make up 25-30% of the field staff at the agency, Chappell said. He pointed out that after the training, ORA will have a “valuable resource available to us.”