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.
Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases Guidance for Sponsor-Investigators
CVM GFI #188 Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine
Animal & Veterinary
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry
Animal & Veterinary, Biologics, Drugs