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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Laws Enforced by FDA
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
- 04/07/2017 - Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications - Final
- 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 #187 Regulation of Intentionally Altered Genomic DNA in Animals - Draft
- 01/19/2017 - Draft Guidance for Industry: Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations - 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
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