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Office of Regulatory Policy


Who We Are:

The Office of Regulatory Policy (ORP) provides oversight and leadership to the Center in the development of policies and procedures related to the regulation of human drugs. Composed of five divisions, ORP is responsible for managing the development of new regulations and policies under the Federal Food, Drug, and Cosmetic Act and other applicable authorities.

What We Do:

  • Initiate, develop, and review regulations, guidance, and other documents related to the regulation of human drugs.
  • Lead efforts to resolve issues cited in citizen petitions and in the development of detailed responses to those petitions.
  • Advise and assist on the scope, applicability and meaning of the Food, Drug, and Cosmetic Act and other applicable laws, regulations, and policies; and assist with developing responses to new legislative proposals.
  • Provide overall policy direction, coordination, and clearance of all requests for information that raise issues concerning the appropriateness of the disclosure.
  • Direct the design, development and implementation of information disclosure policies throughout CDER to ensure compliance with the Freedom of Information Act, Privacy Act and other statutes, and FDA's information disclosure regulations.

Office Organization:

  • Office of Regulatory Policy – Immediate Office
  • Division of Regulatory Policy I
  • Division of Regulatory Policy II
  • Division of Regulatory Policy III
  • Division of Regulatory Policy IV
  • Division of Drug Information Disclosure Policy

Contact Us:

Telephone: 301-796-3600

Office of Regulatory Policy, Immediate Office – Room 6269, 10903 New Hampshire Avenue, Silver Spring, MD 20993