The FDA is attempting to attract scientists, engineers and health professionals in an effort to build expertise in critical areas that the agency is currently lacking.
“Our device expertise in the field has shrunk. We need to grow that. We need to build that expertise from the ground up,” Timothy Ulatowski, director of the office of compliance within the Center for Devices and Radiological Health told FDA News.
Although the FDA is hiring new investigators for its food and drug facilities programs, “there will be additional activity in the device area as far as resources,” Ulatowski said.
As momentum builds for increased funding for the agency, almost all of the leadership at the office of regulatory is leaving, including Associate Commissioner of Regulatory Affairs Margaret Glavin, who is retiring, and Assistant Commissioner for Compliance Policy David Horowitz, who was recently promoted to assistant commissioner for policy for the FDA. Deputy Director Deborah Ralston has left the agency as well.
“It’s an entirely new leadership,” Ulatowski said. “It’s going to be an exciting time as not only people are changing but issues are changing.”
To combat the loss of expertise, the agency is launching a two-year fellowship program that will provide participants with advanced training in the scientific analysis involved in the safety and regulatory decisions particular to the agency’s mission.
Applicants are being considered for the first entering class of the program, which will begin in October. The agency is seeking physicians, microbiologists, chemists, statisticians, pharmacists, biomedical engineers, nutritionists, veterinarians and other science professionals. Applicants should have a doctoral degree in medicine or another scientific field; engineers must have at least a bachelor’s degree. The agency said that between 30 and 40 applicants will be accepted for the first entering class.
The FDA Commissioner’s fellowship program will include coursework and extensive hands-on experience in the agency’s regulatory science department, including regulatory review opportunities.
During the first semester, each fellow will identify an in-depth research project to be completed during the program, allowing each fellow to explore a specific area of interest under the guidance of a senior FDA scientist who will serve as a preceptor. Fellows will devote about 70 percent of their time to the scientific project and 30 percent to coursework.