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The FDA is planning an assortment of activities in 2016 to push for greater diversity in clinical trials, says Robert Califf, the presidential nominee to head the agency. Read More
With the clinical trials industry facing its lowest rates of recruitment and retention, drug developers must incorporate big data and patient voices to improve trial efficiency and hasten innovation, says a new report by the Tufts Center for the Study of Drug Development. Read More
The UK’s healthcare cost watchdog has issued a final guidance that will reimburse seven biologicals as options for treating severe rheumatoid arthritis in patients who have not responded to conventional treatments. Read More
The road to grabbing the title of FDA commissioner keeps getting tougher for Robert Califf, with Sen. Bernie Sanders (I-Vt.) becoming the latest lawmaker to place a hold on his nomination. Read More
Batches of hastily assembled drug products distributed too soon and failure to document quality systems activities were among a host of GMP issues drugmakers violated, sometimes more than a year after the FDA first expressed concerns about companies’ repeated lapses during inspections. Read More