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Regulatory Information

Search for FDA guidance documents, learn about the laws enforced by FDA, and more.

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Search for FDA Guidance Documents

Search for official FDA guidance documents and other regulatory guidance for all topics.

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Laws Enforced by FDA

The Federal Food, Drug, and Cosmetic Act and other congressional milestones are presented in this section.

Standards

FDA participates in the development of standards and uses standards to fulfill its regulatory responsibilities.

Freedom of Information

Electronic reading rooms contain publicly releasable agency records and other information routinely made available.

Dockets Management

Dockets management serves as the official repository for the administrative proceedings and rule-making documents for FDA.

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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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How to Make a FOIA Request

Guidelines for making a Freedom of Information Act request for public information.
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Federal Food, Drug, and Cosmetic Act

Online access to the FDA's principal authorizing legislation.

Resources for You

Approvals & Clearances

Approvals of FDA-Regulated Products

About FDA Product Approval

Recently Published Guidances

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