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