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The EMA identified ways to address the drawbacks of using electronic healthcare records and real-world evidence to support drug development and regulatory decision-making. Read More
International guidance on pediatric drug development should include provisions for remote electronic consent, and should clarify the information provided to patients prior to their enrollment in clinical trials, according to the Association of Clinical Research Organizations. Read More
Pick and Pay, also doing business as Cili Minerals, was ordered to cease operations by a federal district judge until it gets written permission from the FDA to resume. Read More
The head of the brand-name pharmaceutical industry’s trade group called for streamlining of the generics approval process, and a greater shift to value-based payments. Read More
The European Medicines Agency’s working group on good clinical practices and inspections outlined its goals for 2017, including plans to prioritize certain site inspections. Read More