Rules & Regulations
Summary of the FDA's process for rulemaking.
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.
Nov 07
Biologics, Drugs
Nov 07
Biologics, Drugs
Nov 06
Drugs