FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs
FDA is evaluating the root cause of benzene contamination in certain drugs and alerting drug manufacturers to the risk of…
Frequently requested or proactively posted drug-specific and other records
Frequently requested or proactively posted drug-specific and other records
Office of Prescription Drug Promotion (OPDP) Metrics
FDA believes it is critically important to ensure that the promotional messages companies use to introduce new drugs are accurate…
Internet Pharmacy Warning Letters
Rogue online pharmacies offer potentially dangerous prescription drugs to U.S. consumers. FDA has issued warning letters informing the website operators…
Workplace Drug Testing—Prevalence of Positive Test Results, Most Common Substances, and Importance of Medical Review
Among 23,900 urine and oral fluid drug tests from Swedish workplaces, 4.6% tested positive for controlled substances. Cannabis, amphetamine, cocaine…
Inactive Ingredients Database Download
Data updated through July 2024
Quarterly Inactive Ingredient Database (IID) Change Log
Quarterly IID Change Log displays changes made since the previous quarterly IID publication.
FDA Approves First Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disease
The FDA approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug…
Patient Listening Session Summaries
Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement…
eCTD Submission Standards for eCTD v4.0 and Regional M1
A listing of the Implementation Guides, Specifications, and Documentation that support the FDA implementation for eCTD v4.0