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. Office of the Commissioner
  5. Office of Policy, Legislation, and International Affairs
  6. Office of Policy
  1. Office of Policy, Legislation, and International Affairs

Office of Policy

Ritu Nalubola, Associate Commissioner for Policy

Mission

We develop and coordinate the review and analysis of broad agency policy that furthers the FDA’s mission to protect and promote public health, ensure consistency in the development and content of agency policy, and ensure that regulations and other agency documents to be published in the Federal Register meet all applicable requirements.

Major Functions

Our office consists of two components: the Policy Engagement and Coordination Staff, and the Regulations, Policy and Management Staff. We advise the Commissioner, the Deputy Commissioner for Policy, Legislation and International Affairs, and other key department or agency officials on matters relating to agency policy and regulations development. We act as the FDA’s focal point for developing broad agency policy and are the agency's liaison for intergovernmental policy development. We oversee, direct and coordinate the agency’s rulemaking activities and regulations development system, including editing, processing and preparing documents for publication in the Federal Register and initiate new systems and procedures to make the agency's rulemaking process more efficient.

Professional Expertise

The Office employs staff with a broad range of backgrounds and expertise, including healthcare practitioners, scientists, public health specialists, public policy specialists and attorneys.

Contact the Office of Policy

Associate Commissioner for Policy: Ritu Nalubola
Phone: 240-893-4705 | Email: ritu.nalubola@fda.hhs.gov 

Policy Engagement and Coordination Staff: Zahava Hurwitz, Director
Phone: 301-796-5257 | Email: zahava.hurwitz@fda.hhs.gov

Regulations Policy and Management Staff: Tarita Rooths, Acting Director
Phone: 301-796-9138 | Email: tarita.rooths@fda.hhs.gov

Regulations Editorial Section: Dawn Shaw, Section Chief
Phone: 240-907-6466  |  Email:dawn.shaw@fda.hhs.gov  
 



Contact Us

Office of Policy
Office of Policy Headquarters
FDA White Oak Campus

19903 New Hampshire Avenue
Building 32, Room 4239
Silver Spring, MD 20993-0002
United States


Back to Top