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FDA releases the 19-page form FDA-483 with seven observations from an inspection at the Lupin drug manufacturing facility in Verna...[ Price : $8.95]
A new JAMA Health Forum analysis examines FDAs shift in how it seeks outside scientific advice while shunning advisory committee m...[ Price : $8.95]
FDA grants Pilatus Biosciences a fast-track designation for its lead drug candidate, PLT012, for treating hepatocellular carcinoma...[ Price : $8.95]
Minutes from a 1/21 GDUFA 4 reauthorization negotiating session show back and forth between FDA and industry participants on sever...[ Price : $8.95]
FDA warns Dr. Bertrand Cole in Portsmouth, NH, about failing to conduct a clinical study according to the investigational plan.[ Price : $8.95]
FDA reverses course and agrees to review Modernas seasonal influenza mRNA vaccine after previously refusing to file the BLA.[ Price : $8.95]
The Sedgwick Recall Index year-end report for 2025 finds that the number of medical device recalls dropped compared to 2024, while...[ Price : $8.95]
An FDA perspective in the New England Journal of Medicine outlines the agencys move away from requiring two pivotal trials for dru...