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Digital Health Centers of Excellence
Digital Health Center of Excellence
The Digital Health Center of Excellence provides centralized expertise and serves as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff.
Office of Digital Transformation
ODT's 5 Offices
FDA’s IT Strategy: Unlocking Potential, Leading Transformation
The Office of Digital Transformation (ODT) provides the vision and leadership in information technology (IT), data, and cybersecurity needed to advance FDA’s mission and strategic priorities. Led by the Chief Information Officer, Vid Desai, ODT reports to the FDA Commissioner Office. To provide maximum value to the FDA, ODT directs and coordinates enterprise strategic planning, policy, and resource management for all technology, cybersecurity, and data needs. ODT is comprised of 5 offices. We have 6 strategic priorities that guide our efforts as we implement the FDA Information Technology Strategy for Fiscal Years 2024 to 2027 (IT Strategy). This strategy provides a roadmap for technological advancement and alignment with our broader public health mission.The Office of Digital Transformation (ODT) provides the vision and leadership in information technology (IT), data, and cybersecurity needed to advance FDA’s mission and strategic priorities. ODT is led by the Chief Information Officer and reports to the FDA Commissioner. ODT directs and coordinates enterprise strategic planning, policy, and resource management to ensure that Agency IT, data, and cybersecurity investments and activities provide maximum value to FDA. ODT is comprised of the Office of Information Management and Technology (OIMT), Office of Enterprise Portfolio Management (OEPM), Office of Information Security (OIS), Office of Data, Analytics, and Research (ODAR), and Office of Organizational Excellence (OEX) under the direction of the Chief Technology Officer (CTO), Chief Data Officer (CTO), and Chief Information Security Officer (CISO). OIMT is compromised of the Office Customer Experience (OCX) and Office of Technology and Delivery (OTD).
Office of Clinical Policy & Programs
The Office of Clinical Policy and Programs (OCPP) in the Office of the Commissioner promotes safe, effective and innovative medical products for patients through agency-wide collaboration on combination products, ethical conduct of clinical research, orphan product development, patient engagement and pediatric therapeutics.
What We Do
  • Promote scientific policies that support ethical clinical trials and medical product development for adult and pediatric patients.
  • Determine orphan, rare pediatric disease, humanitarian use device and combination product designations.
  • Engage patients to learn about their experiences and help inform medical product development and regulation.
  • Administer grants for research related to orphan product and pediatric device development.
  • Coordinate safety reviews of medical products available for children.
  • Protect the rights and welfare of people participating in clinical trials.
  • Coordinate timely and effective premarket review of combination products.
  • Promote collaboration between FDA and international regulators to facilitate global pediatric drug development.
Office of Clinical Policy (OCLiP)
The Office of Clinical Policy (OCLiP) develops good clinical practice and human subject protection policies, regulation and guidance, and addresses key clinical policy issues across the FDA’s medical product centers. Additionally, OCLiP supports guidance and policy development across medical product programs such as combination products, pediatric therapeutics and orphan product development. OCLiP is comprised of the clinical policy program and the good clinical practice program.What We Do

Develop and implement clinical policy related to medical product development and regulation.
Coordinate and collaborate with offices across the FDA on timely and consistent clinical policy to advance FDA’s public health mission.
Coordinate across the FDA for good clinical practice and human subject protection regulation, international harmonization and outreach activities.
Coordinate and implement regulations, policies, operational initiatives and program priorities related to good clinical practice and human subject protection.
Advise and assist the Commissioner and other key officials across the FDA on ethical issues in clinical trials that may have an impact on policy and the safety of people participating in clinical trials.
Serve as the liaison to other federal agencies and external stakeholders to protect the rights, safety and welfare of people participating in clinical trials.
Plan and provide training to internal and external stakeholders on FDA’s good clinical practice and human subject protection policies.
Office of Orphan Products Development (OOPD)
The FDA Office of Orphan Products Development (OOPD) supports and advances the development and evaluation of new treatments for rare diseases. OOPD evaluates information from product sponsors to determine if drugs, biologics or medical devices meet the criteria for certain incentives and administers grants to provide funding for research on rare diseases. The office also works on rare disease issues with medical and research communities, professional organizations, academia, government agencies, industry and rare disease patient groups. What We Do: Work with sponsors to determine if their products meet the criteria for certain categories (e.g., orphan drug, rare pediatric disease drug or humanitarian use device designations).
Provide orphan status to drugs and biologics which are intended to treat, diagnose or prevent rare diseases that affect fewer than 200,000 people in the U.S.
Designate medical devices that intend to benefit patients in treating or diagnosing a disease or condition that affects fewer than 8,000 individuals in the U.S. per year.
Work with the Office of Pediatric Therapeutics and product centers to determine rare pediatric disease designation for drugs or biologics that meet certain criteria. Sponsors of such product applications may qualify for a priority review voucher, which can be redeemed to receive a priority review of a subsequent marketing application for a different product.
Award grants to provide funding for clinical trials and natural history studies that advance rare disease medical product development.
Award grants that provide funding to develop nonprofit consortia to facilitate pediatric medical device development.
Awards grants and contracts to use in the development of tools, methods and processes to characterize the natural history of rare neurodegenerative diseases, to identify molecular targets for these diseases, and to increase efficiency and productivity of new treatment development.
Office of Pediatric Therapeutics (OPT)
The Office of Pediatric Therapeutics (OPT) helps assure access for children to innovative, safe and effective medical products. What We Do: Work with scientific experts across the FDA to help assure pediatric studies are designed and conducted according to current scientific principles to inform medical product development, review and decision making.
Help assure children are only enrolled in clinical studies that are scientifically necessary and ethically appropriate.
Engage international regulators to help assure children around the world participate in clinical trials that meet international regulatory standards so pediatric trials are not needlessly repeated.
Coordinate the FDA’s Pediatric Advisory Committee to obtain independent expert advice on scientific, clinical, technical and policy matters surrounding pediatric research.
Coordinate pediatric safety reviews by the Pediatric Advisory Committee for certain medical products marketed for children.
Promote development of safe and effective medical products for neonates and infants by encouraging and supporting the FDA’s medical product centers as we address the unique opportunities and challenges involved in evaluating products in neonates.
Collaborate across the agency to designate diseases for the FDA’s rare pediatric disease designation program to encourage development of new medical products for rare pediatric diseases. 
Patient Affairs Staff
The Patient Affairs Staff is a team in the Office of the Commissioner dedicated to providing an inviting, welcoming and meaningful experience for patient communities to engage with the FDA. What we do: Lead patient engagement activities across the agency through:
Crosscutting programs and activities
Public-private collaborations and partnerships
Expanding public awareness and helping patients, caregivers and advocates navigate the FDA engagement opportunities and regulatory processes through various initiatives
Office of External Affairs
Serves as the central point of communication and education about the FDA’s public health and regulatory activity. This includes the development, coordination, and leadership of all FDA communications and outreach efforts to the news media, health professionals, patient advocates, industry, states, consumer groups, and the general public. OEA also serves as the focal point for speechwriting, creative and editorial services, and best practices in digital and web technology.
Advises the Commissioner, Deputy Commissioners and other key agency officials on FDA’s communications to the media, Congress, and the general public on issues that affect agency-wide programs, projects, strategies, partnerships and initiatives.
Advises and assists the Commissioner and other key officials on all public information programs; acts as the focal point for disseminating news on FDA activities and as a liaison with the Department of Health and Human Services on public information programs.
Advises the Commissioner, Deputy Commissioners and other senior staff throughout FDA on sensitive and controversial programs and initiatives that affect external stakeholder groups; provides historical expertise and records to inform those decisions.
Coordinates Agency-wide communication activities.
Ensures consistent visual identity and messaging across the Agency.
Provides communication expertise and state-of-the-art digital guidance and tools for application across the Agency.
Leads efforts to enhance FDA's communications infrastructure to better serve the public.
Serves as a Liaison between FDA and health professional and patient advocacy organizations to solve problems and address concerns these groups have with agency policies and programs related to human and medical product development and safety.
Coordinates and implements policies, programs and initiatives related to MedWatch, including MedWatch website and e-list.
Manage speaker requests for issues that cut across the FDA's organizational and product lines, as well as major meetings that involve various FDA Centers and Offices.
Office of Minority Health & Health Equity
Enhance EQUITY Initiative
Minority Health & Equity
Clinical Trial Diversity
The FDA Office of Minority Health and Health Equity (FDA OMHHE) serves to promote and protect the health of diverse populations through research and communication of science that address health disparities.
Office of Policy, Legislation, & International Affairs
FDA’s Office of Policy, Legislation and International Affairs (OPLIA) is comprised of a constellation of offices and staff, with employees stationed around the globe. Our offices include FDA’s Office of Policy, Office of Legislation, Office of Congressional Appropriations, Office of Global Policy and Strategy, Office of Economics and Analysis and the Intergovernmental Affairs Staff.     

Within FDA, OPLIA has a significant and wide-reaching role. Our staff serves as FDA’s focal point for engagement with the U.S. Congress, the Administration, global counterparts and partners, and state, local, territorial, and tribal policymakers. We offer strategic policy direction to develop and advance policies that protect and promote the public health.  

OPLIA is led by the Deputy Commissioner for Policy, Legislation, and International Affairs. One of OPLIA’s strongest assets is the diversity of its staff. Our work requires collaboration and ingenuity which is only enhanced by the range of professional backgrounds OPLIA staff bring to the table – including law, science, policy, economics, and management. OPLIA’s work is also positively influenced by the diversity of our staff’s personal backgrounds and individual commitment to FDA’s mission to serve the public health.  


Through strategic leadership and engagement with diverse partners, including domestic, tribal, and international decision-makers, OPLIA utilizes our cross-cutting perspective of FDA, expertise in policy, economic analysis, legislation, international and intergovernmental affairs, and understanding of FDA’s stakeholders’ needs, to develop and advance policies that protect and promote the public health.   
Office of Policy
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.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 rule-making process more efficient.
Office of Legislation
The Office of Legislation (OL) directs and manages FDA interactions with Congress, ensures that Congress has the most accurate and up-to-date information regarding FDA regulatory actions, coordinates legislative activities with the Department of Health and Human Services, and manages FDA’s response to requests from the various entities that serve Congress (CRS, CBO, and GAO). In addition, OL provides essential information and guidance on relevant Congressional actions to FDA Leadership and advises them in advance of hearings and other key engagements. Functions

Advises and assists the Commissioner and other key agency officials concerning legislative needs, pending legislation and oversight activities that affect FDA.
Serves as the focal point for overall legislative liaison activities within FDA and between FDA, HHS, and other agencies; and analyzes the legislative needs of FDA and drafts or develops legislative proposals, position papers, and departmental reports on proposed legislation for approval by the Commissioner.
Advises and assists Members of Congress and congressional committees and staffs in consultation with the Office of the Secretary on agency actions, policies, and issues related to legislation which may affect FDA.
Prepares the FDA Commissioner and other senior FDA officials to testify at Congressional hearings; 
Analyzes pending legislation to assess likely impact on FDA; 
Monitors and keeps the FDA community informed about key legislative developments that may affect FDA; 
Briefs Members of Congress and their staffs on FDA priorities and programs; and
Coordinates visits to FDA by Members of Congress and their staffs.

The FDA Reauthorization Act of 2017 (FDARA), signed into law on August 18, 2017, amends the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for drugs, medical devices, generic drugs, and bio-similar biological products, and for other purposes.

The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

The law builds on FDA's ongoing work to incorporate the perspectives of patients into the development of drugs, biological products, and devices in FDA's decision-making process. Cures enhances our ability to modernize clinical trial designs and clinical outcome assessments, which will speed the development and review of novel medical products, including medical countermeasures.

It also provides new authority to help FDA improve our ability to recruit and retain scientific, technical, and professional experts and it establishes new expedited product development programs, including:

The Regenerative Medicine Advanced Therapy, or RMAT, that offers a new expedited option for certain eligible biologics products.
The Breakthrough Devices program, designed to speed the review of certain innovative medical devices.
In addition, the Cures Act directs FDA to create one or more inter-center institutes to help coordinate activities in major disease areas between the drug, biologics and device centers and improves the regulation of combination products

Office of Congressional Appropriations
OCA manages FDA’s relationship with Congressional Appropriators (members of Congress who fund FDA) and serves as the Agency advisor on appropriations matters in support of FDA’s resource needs and public health mission.

Office of Global Policy & Strategy
The Office of Global Policy and Strategy promotes and protects the public health of Americans by ensuring global considerations are fully integrated into FDA policies and operational activities. OGPS does so three ways: 

Through policy coherence: OGPS promotes mutually reinforcing policy actions to advance FDA’s public health and regulatory interests globally.
Through the development of global partnerships: OGPS partnerships will improve compliance with FDA requirements, enhance the capacity of foreign regulatory partners to conduct inspections and laboratory analyses, increase global understanding of the links between strong, well-functioning regulatory systems and public health, economic development, and global trade in goods.
Through the collection, analysis and sharing of high-quality information - including inspection data - to advance FDA’s public health mission. OGPS activities will enhance our risk-based management of regulatory resources, improve our oversight, increase our understanding of complex global supply chains and their effects on the safety and quality of products we regulate, and strengthen capacity to detect and remove violative products and mitigate public health risks through regulatory actions.
OGPS has three sub-offices: The Office of Global Operations (OGO), which includes our foreign posts, the Office of Communications, Evaluation, and Logistics (OCEL), and the Office of Trade and Global Partnerships (OTGP). 

Office of Economics & Analysis
The Office of Economics and Analysis (OEA) provides public health, economic, and strategic analysis and evaluation to inform FDA’s policy and rulemaking decisions. Major Functions: OEA advises and assists the Commissioner and senior leadership on the public health, social science, and economic implications of Agency programs, priorities, and initiatives. 

We conduct economic, public health, social science, and operations research as a basis for analyzing and forecasting trends, needs, and major problems requiring solutions. We also provide assistance and consultation in these areas to FDA leadership and operating units. We evaluate impacts of external factors on Agency programs, including industry market dynamics, consumer expectations, and prospective legislation. OEA develops regulatory impact analysis for FDA’s rulemaking. OEA also leads the Agency’s engagement in GAO and OIG studies through timely clearance and transmission of requested information. 

Intergovernmental Affairs Staff
The Intergovernmental Affairs Staff (IGA) within the Office of Policy, Legislation, and International Affairs is the lead staff dedicated to working with State and Tribal governments within the Office of the Commissioner. The purpose of this staff is to coordinate across FDA Offices, Centers and/or Directorates to respond to inquiries from States and to engage in proactive outreach to States on important FDA policy issues; and to develop and maintain relationships with policymaking State and Tribal partners, including State officials such as Governors, Attorneys General, and State legislators, national associations representing those State officials, and Tribal governments and Tribal organizations
Office of the Chief Scientist
The Office of the Chief Scientist provides strategic leadership, coordination, and research expertise that support scientific excellence, innovation, and capacity to achieve FDA's public health mission.
Office of Women's Health
The Office of Women’s Health (OWH) was established by Congressional mandate in 1994, as part of the Office of the FDA Commissioner, to serve as the principal advisor to the Commissioner and other key Agency officials on scientific, ethical, and policy issues relating to women's health. Provide leadership and policy direction for the Agency regarding issues of women's health and coordinate efforts to establish and advance a women's health agenda for the Agency. Promote the inclusion of women in clinical trials and the implementation of guidelines concerning the representation of women in clinical trials and the completion of sex/gender analysis. Identify and monitor the progress of crosscutting and multidisciplinary women's health initiatives including changing needs, areas that require study, and new challenges to the health of women as they relate to FDA's mission. Serve as the Agency's liaison with other agencies, industry, professional associations and advocacy groups with regards to the health of women. OWH achieves its mission through the foundational principle that Sex as a Biological Variable (SABV) should be factored into research design, analysis, reporting and education. To this end, OWH supports FDA’s regulatory mission by engaging in scientific research and collaborating with stakeholders to engage in scientific and educational projects. These initiatives are coordinated through three program areas: (1) Research and Development (2) Outreach and Communications (3_ Medical Initiatives and Scientific Engagement. To learn more about FDA resources on women's health, visit: Women's Health
Oncology Center of Excellence
OCE Annual Reports
The Oncology Center of Excellence (OCE) was authorized by the 21st Century Cures Act of 2016 and established on January 19, 2017. The Center unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies. The OCE also leads a variety of research and educational outreach projects and programs to advance the development and regulation of medical products for patients with cancer.

Oncology Regulatory Affairs Program
Oncology Regulatory Affairs in the Oncology Center of Excellence (OCE) collaborates with CDER, CBER, and CDRH to develop and execute an integrated regulatory approach to enhance the cross-center coordination of oncology product clinical review. The focus of Oncology Regulatory Affairs is the following:

Develop and implement procedures that affect the regulatory review of medical oncology products across centers.
Interact with colleagues in CDRH, CDER, and CBER to allow for a more coordinated review of products undergoing review by OCE.
Hold internal-facing meetings that allow for OCE policy development.
Provide a forum for oncology Regulatory Affairs to exchange ideas, streamline regulatory review processes and develop regulatory skills in resolving complex regulatory issues.

OCE Pilot Programs:
Oncology Center of Excellence Assessment Aid Pilot Project
The Oncology Center of Excellence developed an Assessment Aid, a voluntary submission from the applicant to facilitate FDA’s assessment of the NDA/BLA application, including supplements.

The Assessment Aid is based on the FDA Multidisciplinary Review template. The main objectives of the Assessment Aid are to (1) focus the FDA review on critical thinking (assessment) and (2) increase review efficiency and consistency, and decrease review time spent on administrative tasks such as formatting.

Oncology Center of Excellence Real-Time Oncology Review Pilot Program
The Oncology Center of Excellence Real-Time Oncology Review (RTOR) aims to provide a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible
Real-Time Oncology Review (RTOR)

Project Facilitate

Oncology Center of Excellence Project Facilitate is a single point of contact call and information center created to help oncology healthcare providers or regulatory professionals submit an Expanded Access Request (also referred to as: Compassionate Use, Emergency IND, Single-Patient IND, or Pre-Approval) for an individual patient with cancer through FDA's Expanded Access Program.

FDA’s Expanded Access Program allows patients with life-threatening diseases or conditions such as cancer try investigational medical products (drug, biologic, or medical device) when no satisfactory therapies are available and there is no opportunity for the patient to enroll in a clinical trial.

Investigational medical products have not yet been approved by the FDA and the FDA has not found these products to be safe and effective for their specific use. The investigational medical products may, or may not, be effective in the treatment of the condition, and use of the product may cause serious side effects that were not expected.

The request process can be complex to navigate, particularly for oncologists who don’t have experience working with clinical trials or these types of requests. To make a request, a member of the patient’s healthcare team will approach the pharmaceutical company to ask for its agreement that it will provide the medical product. The company has the right to approve or disapprove the physician’s request.
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