The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil […]

The Informed Consent Template1 is included as an example in the appendix of FDA’s guidance titled Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers […]

Docket Number: FDA-2026-D-0207 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA, […]

Image Rare Disease News, Events & Reports by Year: 2025 | 2024 | 2023 | 2022 FDA Rare Disease Day FDA will host Rare Disease Day, […]

Image Rare Disease Drug Approvals  2025 | 2024 | 2023 | 2022 | 2021 This page describes select recent rare disease drug approvals announced by a […]

a. What is a rare disease? The Orphan Drug Act defines a rare disease as a disease or condition that affects less than 200,000 people in […]

As part of its mission to protect public health and promote innovation, FDA helps medical product developers translate discoveries in basic science into safe and effective […]