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 Development and Coordination Staff, and the Regulations,
Policy and Management Staff. We advise the Commissioner,
the Associate Commissioner for Policy and Planning, 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 rulemaking
process more efficient.
The Office employs staff with a broad range of backgrounds
and expertise, including healthcare practitioners, scientists,
public health specialists, public policy specialists and attorneys.