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Summary of the FDA's process for rulemaking.
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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.
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.
Approvals & Clearances
Recently Published Guidances
Oct 02
Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”
Drugs
Sep 29
Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling
Medical Devices
Sep 29
Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology
Medical Devices