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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.
Pii to Manufacture FDA-Approved Breast Cancer Drug
September 23rd 2019Pii is now responsible for commercial drug product production of fulvestrant, a breast cancer drug, while Sagent Pharmaceuticals, its abbreviated new drug application holder, will sell, market, and distribute the drug product in the United States.
AstraZeneca’s Combination Diabetes Pill Recommended for Approval in EU
September 23rd 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of AstraZeneca’s Qtrilmet (metformin hydrochloride, saxagliptin, and dapagliflozin) modified-release tablets for treating type-2 diabetes.