[ 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Three stakeholders give technical suggestions to change an FDA draft guidance on data integrity for in vivo bioavailability and bi...[ Price : $8.95]
The Biosimilars Council calls on FDA to eliminate unnecessary clinical efficacy studies as part of streamlining the biosimilar dev...[ Price : $8.95]
FDA publishes a draft guidance on processes and practices for Bioresearch Monitoring inspections.[ Price : $8.95]
A January FDA inspection at Jiangsu Hengrui Pharmaceuticals in Jiangsu, China, leads to an eight-observation Form FDA-483 that cit...