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Latest posts
Last updated about 5 hours ago
FDA Approves First Generic Estradiol Vaginal Insert for Treatment of Moderate to Severe Dyspareunia
about 5 hours ago
The U.S. Food and Drug Administration today approved the first generic version...
FDA Qualifies First AI Drug Development Tool, Will Be Used in 'MASH' Clinical Trials
about 7 hours ago
FDA has qualified the first AI drug development tool, the AI-Based Histologic...
Generic Drugs Program Fiscal Year 2025 Activities Report
about 11 hours ago
As outlined in the GDUFA III Commitment Letter, these performance metrics must...
Counterfeit Medicine
about 11 hours ago
Counterfeit (fake or falsified) medicines may be harmful to your health because...
Generic Drug Research Priorities & Projects
about 13 hours ago
In accordance with the Generic Drug User Fee Amendments (GDUFA), FDA consults...
FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain
3 days ago
FDA continues to investigate counterfeit Ozempic (semaglutide) injection 1 milligram (mg) in...
Food and Drug Omnibus Reform Act (FDORA) of 2022
3 days ago
The Food and Drug Omnibus Reform Act of 2022 (FDORA) requires FDA...
Untitled Letters
3 days ago
These letters are supplied by the CDER Freedom of Information Office and...
FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma
4 days ago
On December 4, 2025, the Food and Drug Administration approved lisocabtagene maraleucel...
Over-the-Counter OTC | Nonprescription Drugs
4 days ago
Over-the-counter (OTC) drugs are developed under the OTC Monograph Process or through...
Drug Trials Snapshot: LYNOZYFIC
4 days ago
LYNOZYFIC is a bispecific antibody used to treat a type of cancer...
Bayesian Statistical Analysis (BSA) Demonstration Project
5 days ago
C3TI aims to increase experience in Bayesian statistical methods in simple trial...