U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. FDA Organization
  4. Center for Drug Evaluation and Research | CDER
  5. Office of Regulatory Policy
  1. Center for Drug Evaluation and Research | CDER

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

Summer 2020 Legal Internship Opportunity:

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Regulatory Policy (ORP), has unpaid internship positions available for law students in summer 2020. ORP provides oversight and leadership in the development of policies and procedures related to the regulation of human drugs and leads efforts to resolve issues cited in citizen petitions submitted to CDER and develop detailed responses to those petitions.

You will work closely with ORP and other CDER staff on projects involving the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other applicable laws, regulations, and policies.  Work will include legal research, writing, and related tasks.  Because ORP considers a variety of complex health policy and drug law issues, this internship offers a challenging work experience and the opportunity to participate on important projects that affect health and safety issues of wide public interest.

To be eligible for the internship, a candidate must be in good academic standing and be available to work approximately 30-40 hours per week.  A successful candidate will possess strong legal research and writing skills and the ability to effectively communicate in a team-oriented environment.  We evaluate candidates based on a variety of factors, including familiarity with the principles of the FD&C Act and administrative law, professional and volunteer experiences, and interest in health law and policy.

To apply for the internship, please send a cover letter, resume, and transcript to: CDER-ORP-DRPI-InternProgram@fda.hhs.gov.

To be considered for a summer 2020 position, applications must be received by ORP no later than Friday, January 31, 2020.

If you have any questions, please feel free to contact us at CDER-ORP-DRPI-InternProgram@fda.hhs.gov or call Katelyn Mineo (301-796-1054) or Aaron Young (301-796-8083).

Food and Drug Administration
Center for Drug Evaluation and Research, Office of Regulatory Policy
10903 New Hampshire Ave.
Silver Spring, MD 20993