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A January FDA inspection at Jiangsu Hengrui Pharmaceuticals in Jiangsu, China, leads to an eight-observation Form FDA-483 that cit...[ Price : $8.95]
Federal Register notice: FDA withdraws 23 NDAs from multiple applicants after being notified by the application holders that the p...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Device Recall Authority 21 CF...[ Price : $8.95]
FDA commissioner Robert Califf and two colleagues make the case for so-called pragmatic clinical research using real-world evidenc...[ Price : $8.95]
Bristol Myers Squibb reports favorable data from a Phase 3 trial evaluating the dual immunotherapy combination of Opdivo (nivoluma...[ Price : $8.95]
FDA warns Mississauga, Canada-based Techlem Medical Corporation about Quality System violations in its manufacture of misbranded w...[ Price : $8.95]
Arrow International recalls (Class 1) its Arrow FiberOptix Intra-Aortic Balloon Catheter Kit after receiving reports about infrequ...[ Price : $8.95]
Three stakeholders give technical suggestions to change an FDA draft guidance on data integrity for in vivo bioavailability and bi...