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.
Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications Document
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry