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The Japan External Trade Organization and that country’s Pharmaceuticals and Medical Devices Authority are looking to enhance ties with Brazil’s Agência Nacional de Vigilância Sanitária on medical products regulations. Read More
York, Pa.-based Unilife has scored a big win after a whistleblower acknowledged that he was wrong in alleging the company failed to comply with FDA requirements. Read More
Medical devicemakers doing business with doctors in Germany will need to exercise extra caution if a proposed anticorruption law goes into effect. Read More
Early this summer, the FDA granted de novo approval to a computer-based tool to assess cognitive decline that may lead to dementia. With more companies looking to develop similar assessment tools, the FDA says it hopes to encourage innovation in this area. Read More
A trade group is calling on India’s Department of Pharmaceuticals to promote incentives for the country’s components industry, saying doing so will help to fuel domestic manufacturing of medical devices. Read More
Pioneer entrants for medical devices face a steeper hurdle than their drug counterparts in gaining approval, according to research from a Harvard professor. Read More
Edwards Life Sciences and San Jose, Calif.-based Align Technology, which markets the Invisalign clear braces system, were among companies caught up in a cyberplot to gain profits from stolen earnings announcements. Read More