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The system, which mirrors a similar EU program, is designed to foster reporting of side effects, which may not have shown up in clinical trials. Read More
The European Commission formally adopted updated regulations on good manufacturing practices for pharmaceuticals generally and for investigational drugs and clinical trials more specifically. Read More
Pennsylvania became the 38th state to pass a “right-to-try” law earlier this month, enacting legislation that aims to increase access by terminal patients to investigational therapies that have cleared Phase I clinical testing. Read More
The European Medicines Agency launched a new plan to streamline procedures for developing advanced gene and cell therapies, including adapting manufacturing requirements to products’ specific challenges. Read More
A group of Iraq War veterans and their families filed a lawsuit this week accusing several drugmakers of contributing to servicemembers’ deaths by indirectly funding militias in Iraq. Read More