This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
News|Articles|January 19, 2017
EMA Releases 2016 Highlights
Author(s)Pharmaceutical Technology Editors
The agency published an overview of marketing authorizations made in 2016.
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On Jan. 17, 2017, the European Medicines Agency (EMA) published an
Some notable highlights from the report include 16 orphan drug designations in 2016. These drugs treat patients with hematology disorders, cancer, hepatology disorders, immunological problems, and metabolism disorders. There were also accelerated assessments made for authorization of treatments for unmet needs including different forms of cancer and chronic hepatitis C infections.
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