Office of Regulatory Review
Who We Are:
The Office of Regulatory Review (ORR) 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, ORR 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 Review – Immediate Office
- Division of Regulatory Review I
- Division of Regulatory Review II
- Division of Regulatory Review III
- Division of Regulatory Review IV
Contact Us:
Telephone: 301-796-3600
Office of Regulatory Review
Immediate Office – Room 6269
10903 New Hampshire Avenue
Silver Spring, MD 20993