Rules & Regulations
Summary of the FDA's process for rulemaking.
On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.
Search for official FDA guidance documents and other regulatory guidance for all topics.
Learn MoreFDASIA 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.
Dec 06
Biologics, Drugs
Dec 05
Drugs
Dec 04
Animal & Veterinary