Office of Regulatory Policy

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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.</p> <h2>What We Do:</h2> <ul> <li>Initiate, develop, and review regulations, guidance, and other documents related to the regulation of human drugs.</li> <li>Lead efforts to resolve issues cited in citizen petitions and in the development of detailed responses to those petitions.</li> <li>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.</li> <li>Provide overall policy direction, coordination, and clearance of all requests for information that raise issues concerning the appropriateness of the disclosure.</li> <li>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.</li> </ul> <h3>Office Organization:</h3> <ul> <li>Office of Regulatory Policy – Immediate Office</li> <li>Division of Regulatory Policy I</li> <li>Division of Regulatory Policy II</li> <li>Division of Regulatory Policy III</li> <li>Division of Regulatory Policy IV</li> <li>Division of Drug Information Disclosure Policy</li> </ul> <h4>Contact Us:</h4> <p>Telephone: <span class="baec5a81-e4d6-4674-97f3-e9220f0136c1" style="white-space: nowrap;">301-796-3600</span></p> <p>Office of Regulatory Policy, Immediate Office – Room 6269, 10903 New Hampshire Avenue, Silver Spring, MD 20993</p> <hr> <h2>Summer 2025 Legal/Regulatory Internship Opportunity</h2> <p style="margin-bottom:11px">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 2025. ORP provides oversight and leadership in the development of policies related to the regulation of human drugs and leads efforts to resolve issues raised in citizen petitions.  </p> <p>Summer interns in ORP work closely with regulatory counsels 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 may 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 in important projects that can affect public health and safety.</p> <p>Applicants 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 professional and volunteer experiences (in particular, those related to health or life sciences), interest in health law and policy, and familiarity with the principles of the FD&C Act and administrative law. Interns will have to pass a security screening.</p> <div class="callout"> <p>To apply for the internship, please send a cover letter, resume, and transcript (official or unofficial) to: <a href="mailto:CDER-ORP-DRPI-InternProgram@fda.hhs.gov">CDER-ORP-DRPI-InternProgram@fda.hhs.gov</a>.</p> <p>To be considered for a summer 2025 position, applications must be received by ORP no later than Friday, January 17, 2025.</p> <p>If you have any questions, please feel free to contact Joe Thomas or Alexandria Fujisaki at <a href="mailto:CDER-ORP-DRPI-InternProgram@fda.hhs.gov">CDER-ORP-DRPI-InternProgram@fda.hhs.gov</a>.</p> </div> <br/> <br></p> <hr>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" 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