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FDAnews held a webinar earlier this month in which three attorneys from Hogan Lovells, including partner Yarmela Pavlovic, explained the FDA’s direct de novo process. The following is adapted from that event. Read More
India’s medical device industry is urging the government to implement several policy measures — including tariff corrections and a new regulatory regime — to ensure the financial viability of domestic device manufacturing parks in the country. Read More
The European Medicines Agency says a defect with Alere’s INRatio blood testing device used in a study does not change the agency’s conclusions on the overall safety or benefit-risk balance of Bayer’s blood thinner Xarelto. Read More
The UK’s healthcare costs regulator is recommending further research on three new tests that speed up the identification of bacteria and fungi in people with suspected bloodstream infections. Read More