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FDA Issues Complete Response Letter for AstraZeneca COPD Drug Application
October 1st 2019AstraZeneca has received a complete response letter from FDA regarding its new drug application for a budesonide/glycopyrronium/formoterol fumarate triple-combination therapy for treating chronic obstructive pulmonary disease.
FDA Gains Approval to Revamp New Drug Review Operations
September 27th 2019After months of planning and explaining, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), finally gained approval for broad changes in its process and procedures for evaluating and approving new drugs.
New Virtual Reality Platform Offers Life Sciences Industry Training
September 27th 2019A new educational platform by Quality Executive Partners offers on-demand digital courses with technical content, virtual reality, and real-time coaching with an initial focus on sterile product manufacturing and microbiology.