Regulatory Information
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.
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Food and Drug Administration Safety and Innovation Act (FDASIA) How to Make a FOIA Request - Guidelines for making a Freedom of Information Act request for public information
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How to Make a FOIA Request Federal Food, Drug, and Cosmetic Act
- Online access to the FDA's principal authorizing legislation
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Federal Food, Drug, and Cosmetic Act (FD&C Act)
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Legislation
The Federal Food, Drug, and Cosmetic Act and other congressional milestones are presented in this section.
Rules & RegulationsRules and regulations help FDA ensure that regulated products are safe and effective.
Search for FDA Guidance DocumentsSearch for official FDA guidance documents and other regulatory guidance for all topics
Dockets Management
Dockets management serves as the official repository for the administrative proceedings and rule-making documents for FDA
Freedom of InformationElectronic reading rooms contain publicly releasable agency records and other information routinely made available.
StandardsFDA participates in the development of standards and uses standards to fulfill its regulatory responsibilities.
Recently Posted Guidance Documents
- 01/19/2017 - CVM GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals - Draft
- 01/19/2017 - CVM GFI #236 Regulation of Mosquito-Related Products - Draft
- 01/18/2017 - Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers Guidance for Industry and Review Staff - Draft
- 01/17/2017 - 2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry - Final
- 01/17/2017 - Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry - Draft
- 01/17/2017 - Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers Guidance for Industry - Draft
- 01/17/2017 - Assessment of Abuse Potential of Drugs - Final
- 01/13/2017 - Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act - Final
- 01/13/2017 - Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff - Final
- 01/13/2017 - Emergency Use Authorization of Medical Products and Related Authorities - Final
Spotlight
- Search all FDA official Guidance Documents and other regulatory guidance
Food and Drug Administration Safety and Innovation Act (FDASIA) International Council for Harmonisation (ICH) Guidance Documents Veterinary International Conference on Harmonization (VICH) Guidance Documents Clinical Investigators - Disqualification Proceedings
Rulemaking
- Comment on proposed regulations and submit petitions
- Unified Agenda of Regulations: Upcoming FDA regulations
- Unified Agenda-TRACK: Search for information on upcoming FDA regulations
- HHS Regulations: Search top HHS regulations, and find and comment on other HHS rules
- HHS Regulation Toolkit: Learn more about regulations and how you can make your voice heard