Regulatory Information
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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 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
- 02/17/2017 - Q11 Development and Manufacture of Drug Substances—Questions and Answers (regarding the selection and justification of starting materials. - Draft
- 02/16/2017 - Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act— Compliance Policy Guidance for Industry - Final
- 02/15/2017 - Guidance Agenda: Guidances CDER is Planning...
- 02/08/2017 - Dear Health Care Provider Letters: Improving Communication of Important Safety Information - Final
- 01/19/2017 - CVM GFI #236 Regulation of Mosquito-Related Products - Draft
- 01/19/2017 - CVM GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals - 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 - Assessment of Abuse Potential of Drugs - Final
- 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
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