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Latest posts
Last updated about 1 hour ago
GDUFA Type II API DMF Payment Receipts Report
about 1 hour ago
GDUFA Type II API DMF Payment Receipts Report
BsUFA III: Fiscal Years 2023-2027
about 1 hour ago
New legislation will be required for FDA to continue collecting biosimilar user...
Notices of Updates
about 2 hours ago
Webpage providing notices of updates to FDA's STIC webpages for antibacterial and...
FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)
about 5 hours ago
On March 19, 2025, the FDA granted traditional approval to pembrolizumab (Keytruda...
FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
about 6 hours ago
On September 10, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO...
Is It Really 'FDA Approved'?
about 7 hours ago
The FDA is responsible for protecting public health by regulating human drugs...
Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned - 09/23/2025
about 8 hours ago
Opening Remarks by Sara Brenner, U.S. Food and Drug Administration September 23...
Center for Drug Evaluation and Research Organization Chart
about 9 hours ago
Organization chart for the FDA's Center for Drug Evaluation and Research, including...
Artificial Intelligence for Drug Development
3 days ago
FDA recognizes the increased use of AI throughout the drug development process...
External Engagements with FDA for Artificial Intelligence in Drug Development
3 days ago
To discuss the use of AI in connection with a specific development...