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An FDA advisory committee unanimously votes to recommend that Covid-19 vaccine makers formulate their upcoming fall shots to provi...[ Price : $8.95]
Amgen announces positive data from its Phase 3 clinical trial (MITIGATE) evaluating the efficacy and safety of Uplizna (inebilizum...[ 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FDA publishes a draft guidance on processes and practices for Bioresearch Monitoring inspections.[ Price : $8.95]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...[ 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...