Navigate the Regulatory Information Section
Rules & Regulations
Summary of the FDA’s process for rulemaking.
Laws Enforced by FDA
The Federal Food, Drug, and Cosmetic Act and other congressional milestones are presented in this section.
Standards
FDA participates in the development of standards and uses standards to fulfill its regulatory responsibilities.
Food and Drug Administration Safety and Innovation Act
FDASIA gives FDA the authority to collect user fees and fund review of innovator drugs, medical devices, generic drugs and biosimilar products.
How to Make a FOIA Request
Guidelines for making a Freedom of Information Act request for public information.
Federal Food, Drug, and Cosmetic Act
Online access to the FDA’s principal authorizing legislation.