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Early human-factor studies can address many questions on usability before combination products enter clinical testing, according to John Towns, a senior research fellow at Eli Lilly & Co. Read More
Developers of medical devices designed to preserve organs for transplant should carefully evaluate the risk of injury to the organs as they test the devices with animal subjects, whether they measure outcomes in vivo or ex vivo, the FDA says in new draft guidance. Read More
The project will focus on modernizing the agency’s regulatory processes and reducing the time, cost and uncertainty of bringing a product to market. Read More
The new assay makes use of “micro-neutralization” technology, which monitors antibodies’ ability to restrain viruses from reproducing themselves in animal cells. Read More
The World Health Organization is developing an Essential Diagnostics List to help countries create their own national lists of essential diagnostic tests and tools. Read More