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A new Government Accountability Office report has found that most companies don’t know the origin of their so-called conflict minerals — tantalum, tin, tungsten and gold — meaning they could be acquiring them from countries rife with humanitarian abuses. Read More
A consumer advocacy group is calling on the FDA to retract draft guidance on patient preference information and end its relationship with a consortium that it maintains is dominated by medical device manufacturers. Read More
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