Cavazzoni Retires as CDER Director

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Editor's Note: This story has been updated to include a comment by Glenn Wright, president and CEO of the Parenteral Drug Association.

An email communication, dated Jan. 10, 2025, released by FDA’s Center for Drug Evaluation and Research (CDER), announced the retirement of CDER Director, Patrizia Cavazzoni, effective January 18.

Cavazzoni joined FDA in 2018 as deputy director of operations in CDER and also served as acting principal deputy commissioner of Food and Drugs briefly in 2019. She was made director of CDER in 2021. Prior to working with FDA, Cavazzoni spent several years working in the pharmaceutical industry in the areas of clinical development, regulatory affairs, and safety risk management (1).

In a letter to her CDER colleagues announcing her retirement, Cavazzoni praised her team for how it handled the COVID-19 pandemic and the growth the center has shown in her years as director (2).

“While I could spend a lot of time enumerating our achievements, I want to highlight our biggest success: our people and our culture,” Cavazzoni said in the letter. “As I leave CDER, I can say with confidence that the Center is at its strongest. We have hired and retained record numbers of the best scientists and professionals. We have built a cohort of world-class managers and executives who are solidly at the helm of our organization and will continue to lead CDER. And most important of all, we created a culture that fosters respect for one another, inclusion, accountability, and diversity of thought and life experience. Our culture is what makes us strong and resilient, and it’s the foundation of what we have accomplished and will accomplish in the future.”

As of the time this article was written, FDA has not yet announced a replacement for Cavazzoni. Her predecessor, Janet Woodcock, was CDER director from 1994 to 2004 and then again from 2007 to 2021 (3).

In a comment provided to Pharmaceutical Technology®, Glenn Wright, president and CEO of the Parenteral Drug Association (PDA), said the following about Cavazzoni's retirement:

“On behalf of PDA and our many industry members worldwide I thank Dr. Cavazzoni for her work as the CDER Center Director within FDA. Her efforts to move the industry and FDA forward to better serve patients is much appreciated. Communication between FDA and Industry is an essential part of ensuring expectations are well understood and concerns and issues raised. Her openness, and that of the Center she leads, to meet with Industry on topics of importance, speak at conferences and attend stakeholder meetings has been very helpful in this rapidly changing world.”

References

1. FDA. Patrizia Cavazzoni, M.D., Director–Center for Drug Evaluation and Research. FDA.gov. April 12, 2021. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/patrizia-cavazzoni
2. CDER Trade Press. CDER Director Patrizia Cavazzoni to Retire from FDA. Email Correspondence. Jan. 10, 2025.
3. FDA. Janet Woodcock, M.D. FDA.gov. Feb. 1, 2024. https://www.fda.gov/about-fda/fda-organization/janet-woodcock