Summary of the FDA's process for rulemaking.
Search for FDA Guidance Documents
Search for official FDA guidance documents and other regulatory guidance for all topics.Learn More
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.
COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry
Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID 19 Public Health Emergency