Summary of the FDA's process for rulemaking.
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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.
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
CVM GFI #159 (VICH GL36) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI
Animal & Veterinary