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The Patient Engagement Collaborative is gearing up for a launch in early 2018. The new, external panel is being built by the FDA and the Clinical Trials Transformation Initiative (CTTI), a public-private partnership between the FDA and Duke University. Read More
The Department of Health and Human Services’ Office of Inspector General sent a letter to PhRMA seeking help in contributing to drug co-payments after a nonprofit ended its financial grants to cover patient co-pays. Read More
Drug pricing will be a key healthcare issue for 2018, with state pricing and transparency laws pushing pharma and life science companies to reconsider strategies and business models, according to a new report from the PwC Health Research Institute. Read More
In 2018, the European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component. Read More