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Biologics

FDA’s Top Ten Drug GMP Citations

At the FDA/Xavier University PharmaLink conference at Xavier University in Cincinnati, Ohio, in March 2017, FDA's Robert Tollefsen and Dell Moller presented the top ten drug GMP inspection citations for FY 2016. As summarized by Elanco's Brent Conatser these citations...

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FDA approves 19 biological licenses in 2017

This year FDA moved to approve 19 new biological licenses including biologics for the treatment of blood cancers and hemophilia. Notably, 2017 saw the approval of a new type of immunotherapy using genetically engineered, patient-derived T-cells, so-called CAR-T cells....

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