Safety labeling update for capecitabine and fluorouracil (5-FU) on ris
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 (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD)...Predictors of Fatal Outcomes among Pediatric Patients Hospitalized for Rocky Mountain Spotted Fever, Sonora, Mexico, 2004–2024
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Emory University School of Medicine, Atlanta, Georgia, USA (S. Bellman,...FDA Medical Product Development Tools
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 new therapies that save lives and improve health care.One important way that FDA does this is by...CDER Rare Diseases Team
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 the United States. b. What is the Orphan Drug Act? The Orphan Drug Act is a law passed by Congress in 1983 that incentivizes the...Rare Disease Drug Approvals
Image Rare Disease Drug Approvals 2025 | 2024 | 2023 | 2022 | 2021This page describes select recent rare disease drug approvals announced by a CDER or FDA communication. To search all FDA-approved drugs, visit Drugs@FDA. Alhemo FDA Approves Drug to Prevent or Reduce...All Drug Purchases Are
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