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Latest posts
Last updated about 7 hours ago
GDUFA Type II API DMF Payment Receipts Report
about 8 hours ago
GDUFA Type II API DMF Payment Receipts Report
BsUFA III: Fiscal Years 2023-2027
about 8 hours ago
New legislation will be required for FDA to continue collecting biosimilar user...
Notices of Updates
about 8 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 11 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 12 hours ago
On September 10, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO...
Is It Really 'FDA Approved'?
about 13 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 14 hours ago
Opening Remarks by Sara Brenner, U.S. Food and Drug Administration September 23...
Center for Drug Evaluation and Research Organization Chart
about 15 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...