CDER Director Discusses Priorities for Fiscal 2023
Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni outlined the center’s budget priorities in fiscal year 2023 in a webinar hosted last week by the Alliance for a Stronger FDA.
CDER’s priorities for the next fiscal year include increased investment in human drug initiatives and providing more support for postmarket safety surveillance and oversight of marketed products, she said.
Among the center’s priorities for fiscal 2023 will be launching a biosimilars regulatory research program, establishing a pregnancy safety workgroup to assess pregnancy outcomes in women who are exposed to drugs and biological products, and activities that will lead to accelerating cures for rare diseases, she said.
Cavazzoni also addressed the question of whether CDER will have sufficient staff to achieve its goals in fiscal 2023. She said that some staff members postponed their retirement plans in order to contribute to the agency’s work in the pandemic. And the current 12-month staff attrition rate is around 8 percent, which is within the prepandemic range. She also said that the center is seeing increased job applicants for the role of medical reviewer, a position that has been hard to fill in the past.
Cavazzoni noted that CDER has continued to meet its non-COVID-related review goals despite the pandemic. “This wasn’t easy,” she said.