U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. FDA Organization
  4. Center for Drug Evaluation and Research (CDER)
  5. Patrick Raulerson,
  1. Center for Drug Evaluation and Research (CDER)

Patrick Raulerson, J.D.
Leadership Role
Director - Office of Regulatory Policy

Patrick Raulerson, J.D.
Patrick Raulerson, J.D.

As Director of CDER’s Office of Regulatory Policy (ORP), Patrick Raulerson, J.D., provides leadership and guidance to the Center regarding policies and procedures related to the regulation of human drugs. He is also the chair of CDER’s Strategic Policy Council.

Since joining ORP in 2009, Mr. Raulerson has served as regulatory counsel, senior regulatory counsel, and acting deputy director. He has led multiple legislative initiatives culminating in new or revised statutory authorities that have strengthened CDER’s ability to appropriately regulate human drugs. These include key reforms to FDA’s accelerated approval pathway, inspection authorities, medical gas regulation, and drug safety tools used to address the opioid crisis.

Mr. Raulerson holds a bachelor’s degree in chemistry and English from Oberlin College and a juris doctor degree from the University of Michigan Law School.

Related Information

Back to Top