- FDASIA gives FDA the authority to collect user fees and fund review of innovator drugs, medical devices, generic drugs and biosimilar products.
- Guidelines for making a Freedom of Information Act request for public information
- Online access to the FDA's principal authorizing legislation
Navigate the Regulatory Information Section
The Food and Drugs Act of 1906 and other congressional milestones are presented in this section.Rules & Regulations
Rules and regulations help FDA ensure that regulated products are safe and effective.Guidances
Guidances represent FDA's current thinking on a topic. They do not create/confer rights or bind FDA or the public.
Dockets management serves as the official repository for the administrative proceedings and rule-making documents for FDAFreedom of Information
Electronic reading rooms contain publicly releasable agency records and other information routinely made available.Standards
FDA participates in the development of standards and uses standards to fulfill its regulatory responsibilities.
Regulations and Rulemaking
Comment on Proposed Regulations and Submit Petitions
How to participate in the rulemaking process
Unified Agenda of Regulations
Semi-annual agenda of FDA's upcoming regulations
Search for information about upcoming FDA regulations
Search top Department of Health and Human Services regulations, and find and comment on other HHS rules
HHS Regulations Toolkit
Learn more about regulations and how you can make your voice heard